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This investigation was designed to determine the effect of melatonin supplementation on mental health parameters, metabolic and genetic profiles in patients under methadone maintenance treatment (MMT). This randomized, double-blind, placebo-controlled, clinical trial was conducted among 54 patients under MMT. Participants were randomly allocated to receive either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 26) or placebo (n = 28) once a day, 1 hour before bedtime for 12 weeks. Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (β -4.08; 95 percent CI, -5.51, -2.65; P < 0.001), Beck Depression Inventory index (β -5.46; 95% CI, -8.92, -2.00; P = 0.003) and Beck Anxiety Inventory index (β -3.87; 95% CI, -5.96, -1.77; P = 0.001) and significantly increased International Index of Erectile Functions (β 5.59; 95% CI, 1.76, 9.42; P = 0.005) compared with the placebo. Subjects who received melatonin supplements had significantly lower serum insulin levels (β -2.53; 95% CI, -4.48, -0.59; P = 0.01), homeostasis model of assessment-insulin resistance (β -0.56; 95% CI, -1.03, -0.09; P = 0.01) and higher quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.004, 0.02; P = 0.009) and HDL-cholesterol levels (β 3.71; 95% CI, 1.77, 5.64; P = 0.002) compared to placebo. Additionally, melatonin intake resulted in a significant reduction in serum high sensitivity C-reactive protein (β -0.15; 95% CI, -0.27, -0.02; P = 0.02), malondialdehyde (β -0.31; 95% CI, -0.57, -0.05; P = 0.02) and protein carbonyl (β -0.06; 95% CI, -0.09, -0.04; P < 0.001). This trial indicated that taking melatonin supplements for 12 weeks by patients under MMT had beneficial effects on their mental health metabolic profiles. [ABSTRACT FROM AUTHOR]

This study was carried out to determine the effects of magnesium and vitamin E co‐supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). The current randomized, double‐blind, placebo‐controlled trial was conducted among 57 patients with grade 3 DFU. Participants were randomly divided into two groups to take either 250 mg magnesium oxide plus 400 IU vitamin E (n = 29) or placebo per day (n = 28) for 12 weeks. Compared with the placebo, taking magnesium plus vitamin E supplements reduced ulcer length (β [difference in the mean of outcomes measures between treatment groups] −0.56 cm; 95% CI, −0.92, −0.20; p = 0.003), width (β −0.35 cm; 95% CI, −0.64, −0.05; p = 0.02) and depth (β −0.18 cm; 95% CI, −0.33, −0.02; p = 0.02). In addition, co‐supplementation led to a significant reduction in fasting plasma glucose (β −13.41 mg/dL; 95% CI, −20.96, −5.86; p = 0.001), insulin (β −1.45 μIU/ml; 95% CI, −2.37, −0.52; p = 0.003), insulin resistance (β −0.60; 95% CI, −0.99, −0.20; p = 0.003) and HbA1c (β −0.32%; 95% CI, −0.48, −0.16; p < 0.003), and a significant elevation in insulin sensitivity (β 0.007; 95% CI, 0.003, 0.01; p < 0.001) compared with the placebo. Additionally, compared with the placebo, taking magnesium plus vitamin E supplements decreased triglycerides (β −10.08 mg/dL; 95% CI, −19.70, −0.46; p = 0.04), LDL‐cholesterol (β −5.88 mg/dL; 95% CI, −11.42, −0.34; p = 0.03), high sensitivity C‐reactive protein (hs‐CRP) (β −3.42 mg/L; 95% CI, −4.44, −2.41; p < 0.001) and malondialdehyde (MDA) (β −0.30 μmol/L; 95% CI, −0.45, −0.15; p < 0.001), and increased HDL‐cholesterol (β 2.62 mg/dL; 95% CI, 0.60, 4.63; p = 0.01) and total antioxidant capacity (TAC) levels (β 53.61 mmol/L; 95% CI, 4.65, 102.57; p = 0.03). Overall, magnesium and vitamin E co‐supplementation for 12 weeks to patients with DFU had beneficial effects on ulcer size, glycemic control, triglycerides, LDL‐ and HDL‐cholesterol, hs‐CRP, TAC, and MDA levels. [ABSTRACT FROM AUTHOR]

Background: Data on the effects of omega-3 fatty acid supplementation on clinical symptoms and metabolic profiles in patients with endometrial hyperplasia (EH) are limited. This intervention was performed to assess the effects of omega-3 fatty acid supplementation on clinical symptoms and metabolic profiles in patients with endometrial hyperplasia (EH). Methods: This randomized, double-blind, placebo-controlled trial was conducted among 40 women diagnosed with simple endometrial hyperplasia (EH). EH diagnosis was performed based on specific diagnostic procedures of biopsy. Participants were randomised into two groups to intake 1,000 mg omega-3 fatty acid supplements from flaxseed oil (n = 20) or placebo (n = 20), twice a day for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related markers. Results: Compared with the placebo, omega-3 fatty acid supplementation significantly decreased fasting plasma glucose (FPG) (-7.1 ± 9.6 vs. +2.0 ± 4.9 mg/dL, P = 0.001), serum insulin levels (-1.5 ± 4.6 vs. +1.6 ± 3.9 µIU/mL, P = 0.02) and homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.4 ± 1.1 vs. +0.4 ± 1.0, P = 0.02). In addition, a significant increase in plasma total antioxidant capacity (TAC) (+102.6 ± 69.6 vs. +5.0 ± 37.1 mmol/L, P < 0.001) and total glutathione (GSH) levels (+63.6 ± 84.9 vs. -3.0 ± 69.4 µmol/L, P = 0.01) were seen following the supplementation of omega-3 fatty acid compared with the placebo. Omega-3 fatty acid supplementation had no significant effect on regression, lipid profiles, and other biomarkers of inflammation and oxidative. Conclusions: In conclusion, we found that omega-3 fatty acid administration for 12 weeks to subjects with EH significantly improved FPG, insulin, HOMA-IR, TAC and GSH levels, but did not influence regression, lipid profiles, and other biomarkers of inflammatory and oxidative stress. [ABSTRACT FROM AUTHOR]

Introduction: Data on comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with polycystic ovary syndrome (PCOS) are scarce. This purpose of this study was to compare of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with PCOS.Methods: This randomized controlled trial was conducted among 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to intake either myo-inositol (n = 30) or metformin (n = 30) for 12 weeks. Parameters of mental health were recorded at baseline and after the 12-week intervention. Fasting blood samples were obtained at baseline and the end of the study to determine biomarkers of biomarkers of oxidative stress.Results: After the 12-week intervention, changes in beck depression inventory total score (-1.0 ± 1.7 vs. -0.3 ± 0.7, p = 0.03), general health questionnaire scores (-1.7 ± 2.9 vs. -0.5 ± 1.2, p = 0.02), depression anxiety and stress scale scores (-3.9 ± 6.4 vs. -0.9 ± 1.9, p = 0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1 ± 69.6 vs. +2.1 ± 132.4 mmol/L, p < 0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group. Myo-inositol supplementation for 12 weeks among patients with PCOS did not affect plasma glutathione and malondialdehyde levels.Conclusions: Overall, our data supported that myo-inositol supplementation for 12 weeks among patients with PCOS had favorable effects on parameters of mental health and plasma TAC levels. [ABSTRACT FROM AUTHOR]

Background: Data on the effects of folic acid supplementation on clinical symptoms and metabolic profiles of patients with endometrial hyperplasia (EH) are limited. This investigation was performed to evaluate the effects of folic acid supplementation on clinical symptoms and metabolic status of patients with EH. Methods: This randomized, double-blind, placebo-controlled trial was conducted among 60 women diagnosed with EH. Diagnosis of EH was made based on biopsy results. Participants were randomly allocated to 2 groups to take 5 mg/d folic acid supplements (n = 30) or placebo (n = 30) for 12 weeks. Results: After the 12-week intervention, folic acid supplementation significantly decreased fasting plasma glucose (β -3.99 mg/ dL; 95% CI, -7.39, -0.59; P = 0.02), serum insulin levels (β -2.82 µIU/mL; 95% CI, -4.86, -0.77; P = 0.008), homeostasis model assessment for insulin resistance (β -0.68; 95% CI, -1.20, -0.17; P = 0.009), triglycerides (β -16.47 mg/dL; 95% CI, -28.72, -4.22; P = 0.009) and very-low-density lipoprotein (VLDL) cholesterol (β -3.29 mg/dL; 95% CI, -5.74, -0.84; P = 0.009), and significantly increased the quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.004, 0.03; P = 0.01) compared with the placebo. Additionally, folic acid intake resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.36 mg/L; 95% CI, -0.52, -0.21; P < 0.001) compared with the placebo. Folic acid supplementation did not affect other metabolic parameters. Conclusion: In conclusion, we found that folic acid administration for 12 weeks to subjects with EH improved glycemic control, triglycerides, VLDL-cholesterol and hs-CRP levels, but did not influence recurrence and other metabolic profiles. [ABSTRACT FROM AUTHOR]

Background: Combined omega-3 fatty acid and vitamin D supplementation may improve multiple sclerosis (MS) by correcting metabolic abnormalities and attenuating oxidative stress and inflammation.Objective: This study aimed to determine the effects of ω-3 fatty acid and vitamin D cosupplementation on the disability score and metabolic status of patients with MS.Methods: This was a randomized, placebo-controlled clinical trial with Expanded Disability Status Scale (EDSS) score and inflammation as primary outcomes and oxidative stress biomarkers and metabolic profile as secondary outcomes. Patients, aged 18-55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n = 53) and randomly received a combined 2 × 1000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo for 12 wk. The placebos were matched in colour, shape, size, packaging, smell, and taste with supplements. Fasting blood samples were collected at baseline and end of intervention to measure different outcomes. Multiple linear regression models were used to assess treatment effects on outcomes adjusting for confounding variables.Results: Patients taking ω-3 fatty acid plus vitamin D supplements showed a significant improvement in EDSS (β -0.18; 95% CI: -0.33, -0.04; P = 0.01), compared with placebo. Serum high-sensitivity C-reactive protein (β -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (β -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group. In addition, ω-3 fatty acid and vitamin D cosupplementation resulted in a significant reduction in serum insulin, insulin resistance, and total/HDL-cholesterol, and a significant increase in insulin sensitivity and serum HDL-cholesterol concentrations.Conclusion: Overall, taking ω-3 fatty acid and vitamin D supplements for 12 wk by patients with MS had beneficial effects on EDSS and metabolic status. This trial was registered at the Iranian website (www.irct.ir) for registration of clinical trials as IRCT2017090133941N20. [ABSTRACT FROM AUTHOR]

Objective: This study was designed to evaluate the effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes among subjects with gestational diabetes (GDM).Methods: This randomized, double-blind, placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly allocated to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum (2 × 109 CFU/g each) (n = 30) or placebo (n = 30) for six weeks.Results: Compared with the placebo, probiotic supplementation resulted in significant decreases in fasting plasma glucose (FPG) (-5.3 ± 6.7 vs. +0.03 ± 9.0 mg/dL, p = .01), serum high-sensitivity C-reactive protein (hs-CRP) (-2.2 ± 2.7 vs. +0.5 ± 2.4 μg/mL, p < .001), plasma malondialdehyde (MDA) concentrations (-0.1 ± 0.8 vs. +0.5 ± 1.5 μmol/L, p = .03) and MDA/TAC ratio (-0.0003 ± 0.0008 vs. +0.0009 ± 0.002, p = .004), and a significant increase in total antioxidant capacity (TAC) levels (+65.4 ± 103.3 vs. -37.2 ± 143.7 mmol/L, p = .002). Probiotic supplementation did not affect pregnancy outcomes.Conclusions: Overall, probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG, serum hs-CRP, plasma TAC, MDA and oxidative stress index, but did not affect pregnancy outcomes. [ABSTRACT FROM AUTHOR]

The current study was conducted to assess the effects of vitamin D supplementation on insulin metabolism, lipid fractions, biomarkers of inflammation, and oxidative stress in diabetic hemodialysis (HD) patients. This randomized double-blind placebo-controlled clinical trial was carried out among 60 diabetic HD patients. Subjects were randomly allocated into two groups to intake either oral vitamin D3 supplements at a dosage of 50 000 IU (n = 30) or placebo (n = 30) every 2 weeks for 12 weeks. After 12 weeks of intervention, subjects who received vitamin D supplements compared with the placebo had significantly decreased serum insulin concentrations (-3.4 ± 3.7 vs. + 2.0 ± 4.2 µIU/ml, p < 0.001), homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-1.2 ± 1.8 vs. + 0.9 ± 2.3, p < 0.001), and improved quantitative insulin sensitivity check index (QUICKI) (+ 0.02 ± 0.03 vs. -0.01 ± 0.02, p < 0.001). In addition, compared with the placebo, vitamin D supplementation led to significant reductions in serum high-sensitivity C-reactive protein (hs-CRP) (-1.4 ± 2.5 vs. + 1.4 ± 4.8 mg/l, p = 0.007), plasma malondialdehyde (MDA) (-0.1 ± 0.2 vs. + 0.1 ± 0.2 µmol/l, p = 0.009) and a significant increase in plasma total antioxidant capacity (TAC) concentrations (+ 33.8 ± 56.7 vs. -2.0 ± 74.5 mmol/l, p = 0.04). We did not see any significant effect of vitamin D supplementation on lipid profiles and other biomarkers of inflammation and oxidative stress compared with the placebo. Overall, we found that vitamin D supplementation had beneficial effects on serum insulin, HOMA-IR, QUICKI, serum hs-CRP, plasma MDA, and TAC levels among diabetic HD patients for 12 weeks. [ABSTRACT FROM AUTHOR]

Background: Vitamin D might be beneficial in diabetic patients with coronary artery disease (CAD) through its favorable effects on metabolic profiles and biomarkers of inflammation and oxidative stress.Objective: This study was performed to examine the effects of 6 mo of vitamin D supplementation on metabolic status in diabetic patients with CAD.Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted in 60 vitamin D-deficient diabetic patients with CAD aged 40-85 y. Subjects were randomly assigned into 2 groups to take either 50,000-IU vitamin D supplements (n = 30) or placebo (n = 30) every 2 wk for 6 mo. Fasting blood samples were obtained at the beginning of the study and after the 6-mo intervention to quantify glycemic indicators, lipid concentrations, and biomarkers of inflammation and oxidative stress.Results: Compared with placebo, vitamin D supplementation resulted in significant reductions in fasting plasma glucose (-14.9 ± 7.1 compared with +19.3 ± 7.1 mg/dL; P = 0.001), serum insulin (-2.7 ± 1.1 compared with +1.8 ± 1.1 μIU/mL; P = 0.006), homeostasis model assessment of insulin resistance (-0.7 ± 0.3 compared with +0.5 ± 0.3; P = 0.01), and β cell function (-9.1 ± 4.2 compared with +5.7 ± 4.2; P = 0.01) and a significant increase in serum vitamin D (+6.8 ± 0.9 compared with +0.1 ± 0.9 ng/mL; P < 0.001) and the Quantitative Insulin Sensitivity Check Index (+0.008 ± 0.004 compared with -0.007 ± 0.004; P = 0.01). In addition, changes in serum high-sensitivity C-reactive protein (hs-CRP; -1.0 ± 0.5 compared with +0.6 ± 0.5 μg/mL; P = 0.02), plasma nitric oxide (NO; +7.0 ± 2.0 compared with -4.6 ± 2.0 μmol/L; P < 0.001), total reduced glutathione (GSH; +104 ± 16.4 compared with +24.8 ± 16.4 μmol/L; P = 0.001), and malondialdehyde concentrations (-0.2 ± 0.1 compared with +0.2 ± 0.1 μmol/L; P < 0.001) in the supplemented group were significantly different from the changes in these indicators in the placebo group.Conclusions: Overall, 6 mo of vitamin D supplementation among vitamin D-deficient diabetic patients with CAD had beneficial effects on glycemic control and serum hs-CRP, NO, GSH, and malondialdehyde concentrations. This trial was registered on the Iranian website (www.irct.ir) for registration of clinical trials as IRCT201510315623N56. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study was conducted to establish the comparative effects of carbohydrate versus fat restriction on metabolic indices in Type 2 diabetic (T2D) patients with coronary heart disease (CHD). METHODS: This randomized, clinical trial was done among 56 overweight persons with T2D and CHD aged 40-85 years old. The patients were randomly allocated to take either a highcarbohydrate (HC) diet (60-65% carbohydrates and 20-25% fats) (n = 28) or a restricted carbohydrate (RC) diet (43-49% carbohydrate and 36-40% fats) (n = 28) for 8 weeks to determine metabolic status. RESULTS: After 8 weeks of treatment, RC diet decreased fasting plasma glucose (FPG) (-11.5 ± 28.3 vs. +7.0 ± 26.9 mg/dl, P = 0.010) and high-sensitivity C-reactive protein (hs-CRP) (-564.3 ± 1280.1 vs. +286.1 ± 1789.2 ng/ml, P = 0.040) compared with a HC diet. Moreover, compared with a HC diet, RC diet increased total antioxidant capacity (TAC) (+274.8 ± 111.5 vs. +20.2 ± 82.5 mmol/l, P < 0.001) and glutathione (GSH) levels (+51.6 ± 111.5 vs. -32.6 ± 88.5 µmol/l, P = 0.003). No significant alterations between the two groups were found in terms of their effect on other metabolic profiles. CONCLUSION: RC diet in overweight T2D with CHD had beneficial effects on FPG, hs-CRP, TAC, and GSH values. [ABSTRACT FROM AUTHOR]

Background: Limited data is available on the effects of multispecies probiotic supplementation on metabolic status in pregnant women in the first half of pregnancy. The current study was carried out to determine the effects of multispecies probiotic capsule supplementation on metabolic status among pregnant women in the first half of pregnancy. Methods: A randomized clinical trial was conducted among 60 pregnant women aged 18-37 years. The participants were randomly divided into two groups: group A (n = 30) received multispecies probiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus, Lactobacillus easel, Bifidobacterium bifidum (2 x 109 CFU/g each) and group B (n = 30) received placebo from 9 weeks of gestation fora duration of 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine metabolic profiles, inflammatory cytokines and biomarkers of oxidative stress. Results: After 12 weeks of intervention, compared to the placebo group, the pregnant women who consumed probiotic capsule had significantly decreased serum insulin concentrations (-1.5 ± 4.8 vs. +1.3 ± 5.2 µlU/mL, P = 0.03), the homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-0.3 ± 0.9 vs. +0.3 ± 1.1, P = 0.04), the homeostasis model of assessment-estimated b cell function (HOMA-B) (-7.2 ± 23.1 vs. +5.3 ± 22.6, P = 0.03) and increased quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.05 vs. -0.01 ± 0.02, P = 0.03). In addition, changes in serum triglycérides levels (-14.7 ± 46.5 vs. +37.3 ± 74.2 mg/dL, P = 0.002), high-sensitivity C-reactive protein (hs-CRP) (-1.0 ± 2.6 vs. +1.7 ± 4.3 mg/L, P = 0.004), plasma nitric oxide (NO) (+6.8 ± 9.3 vs. -4.7 ± 7.4 umol/L, P < 0.001 ), total antioxidant capacity (TAC) (+171.9 ± 187.6 vs. -51.9 ± 208.8 mmol/L, P < 0.001 ) and glutathione (GSH) concentrations (+34.3 ± 71.6 vs. -36.9 ± 108.3 µmol/L, P = 0.004) in supplemented women were significantly different from those of the placebo group. However, after controlling for baseline levels, age and BMI at the study baseline, the changes in plasma GSH were not significantly different between the groups. Conclusion: Overall, probioticsupplementation for 12 weeks among pregnant women in the first half of pregnancy had beneficial effects on markers of insulin metabolism, triglycerides, biomarkers of inflammation and oxidative stress. [ABSTRACT FROM AUTHOR]

Background & Aims This study was designed to determine the effects of the Dietary Approaches to Stop Hypertension ( DASH) diet on weight loss and metabolic status in overweight patients with non-alcoholic fatty liver disease ( NAFLD). Methods This randomized controlled clinical trial was done among 60 overweight and obese patients with NAFLD. Patients were randomly allocated to consume either the control ( n = 30) or the DASH eating pattern ( n = 30) for 8 weeks. Both diets were designed to be calorie-restricted. Both diets were consisted of 52-55% carbohydrates, 16-18% proteins and 30% total fats; however, the DASH diet was designed to be rich in fruits, vegetables, whole grains, and low-fat dairy products and low in saturated fats, cholesterol and refined grains. Results Adherence to the DASH eating pattern, compared to the control diet, weight ( P = 0.006), BMI ( P = 0.01), alanine aminotransferase ( ALT) ( P = 0.02), alkalin phosphatase ( ALP) ( P = 0.001), insulin levels ( P = 0.01), homoeostasis model of assessment-estimated insulin resistance ( HOMA- IR) ( P = 0.01) significantly decreased and quantitative insulin sensitivity check index ( QUICKI) ( P = 0.004) significantly increased. Compared with the control diet, the DASH diet has resulted in significant reductions in serum triglycerides ( P = 0.04) and total-/ HDL-cholesterol ratio ( P = 0.01). Finally, decreased concentrations of serum high-sensitivity C-reactive protein (hs- CRP) ( P = 0.03), malondialdehyde ( MDA) ( P = 0.04), increased levels of nitric oxide ( NO) ( P = 0.01) and glutathione ( GSH) ( P = 0.009) were found in the DASH group compared with the control group. Conclusions Consumption of DASH diet for 8 weeks among patients with NAFLD had beneficial effects on weight, BMI, ALT, ALP, triglycerides, markers of insulin metabolism, inflammatory markers, GSH and MDA. [ABSTRACT FROM AUTHOR]

The article presents the discussion on expression of concern for the effects of selenium supplementation on biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy: a randomised, double-blind, placebo-controlled trial.

The article presents the discussion on expression of concern for the synbiotic supplementation and the effects on clinical and metabolic responses in patients with rheumatoid arthritis.

The article presents the discussion on expression of concern for the effects of magnesium supplementation on carotid intima–media thickness and metabolic profiles in diabetic haemodialysis patients.

The article presents the discussion on expression of concern for the Selenium supplementation lowers insulin resistance and markers of cardio-metabolic risk in patients with congestive heart failure: a randomised, double-blind, placebo-controlled trial.

The article presents the discussion on expression of concern for the effects of vitamin D, K and calcium co-supplementation on carotid intima-media thickness and metabolic status in overweight type 2 diabetic patients with CHD .

AbstractNeuropathic pain, a nerve damage consequence, presents symptoms such as dysesthesia, hyperalgesia, and allodynia. This study aimed to evaluate the alleviating potential of artichoke leaf extract in neuropathic pain induced by chronic constriction injury (CCI) of the sciatic nerve in male rats. The hydroethanolic extract of artichoke leaf was administered via gavage at doses of 200, 400, and 800 mg/kg for 21 days. Behavioural tests were conducted on days 1, 4, 7, 14, and 21 post-surgeries. Only the dose of 800 mg/kg significantly reduced thermal hyperalgesia and allodynia from day 14 and mechanical allodynia from day 7, and the other doses did not affect behaviours. Biochemical analysis showed that artichoke extract decreased lipid peroxidation and restored antioxidant enzyme activities (SOD and GPx) in the sciatic nerve tissue. In conclusion, artichoke leaf extract administration diminishes neuropathic pain-related behaviours by enhancing antioxidant capacity and reducing oxidative stress in the rats’ sciatic nerve. [ABSTRACT FROM AUTHOR]

Background: This study was conducted to assess the effects of folate supplementation on carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress in carbamazepine-treated epileptic children. Methods: This randomized, double-blind, placebo-controlled trial was carried out in 54 epileptic children aged 2–12 years old receiving carbamazepine monotherapy. Participants were randomly allocated into two groups to receive either 5 mg folate supplements or placebo (n = 27 in each group) for 12 weeks. Results: After the 12-week intervention, compared with the placebo, folate supplementation resulted in a significant reduction in plasma homocysteine (Hcy) (changes from baseline − 2.1 ± 2.5 vs. +0.1 ± 0.4 μmol/L, P < 0.001), serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline − 1.5 ± 3.5 vs. +0.4 ± 1.4 mg/L, P = 0.01), a significant increase in plasma nitric oxide (NO) (changes from baseline + 1.9 ± 5.8 vs. −2.0 ± 6.4 μmol/L, P = 0.02), and total antioxidant capacity (TAC) concentrations (changes from baseline + 88.6 ± 116.0 vs. +1.8 ± 77.4 mmol/L, P = 0.002). We did not observe any significant effects in mean levels of left and right CIMT, maximum levels of left and right CIMT, and total glutathione (GSH) and malondialdehyde (MDA) levels following the supplementation of folate compared with the placebo. Conclusions: Overall, folate supplementation at a dosage of 5 mg/day for 12 weeks among epileptic children receiving carbamazepine had beneficial effects on Hcy, hs-CRP, NO, and TAC levels, but did not affect CIMT, and GSH and MDA levels. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to evaluate the effects of mulberry extract administration on markers of insulin metabolism, lipid concentrations, and biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy (DN).Materials and Methods: Sixty patients were randomly allocated into 2 groups to receive either 300 mg/d of mulberry extract (n = 30) or placebo (n = 30), twice per day for 12 weeks. Fasting blood samples were taken at the onset of the study and 12 weeks after supplementation to examine markers of insulin metabolism, lipid concentrations, and biomarkers of inflammation and oxidative stress.Results: Mulberry extract, compared to placebo, resulted in significant reductions in serum triglycerides (-37.3 ± 64.7 mg/dL versus 3.0 ± 78.8 mg/dL, P = .03) and very low-density lipoprotein cholesterol (-7.4 ± 12.9 mg/dL versus 0.6 ± 15.8 mg/dL, P = .03), and a significant increase in high-density lipoprotein cholesterol concentration (0.5 ± 4.0 mg/dL versus -2.0 ± 5.0 mg/dL, P = .03). Other significant changes were in serum high-sensitivity C-reaction protein (-2.3 ± 4.5 µg/mL versus -0.1 ± 2.2 µg/mL, P = .02), plasma glutathione (87.8 ± 159.7 µmol/L versus -24.2 ± 138.8 µmol/L, P = .005) and malondialdehyde (-0.03 ± 0.5 µmol/L versus 0.7 ± 1.0 µmol/L, P < .001).   Conclusions. These findings showed that mulberry extract administration had favorable effects on serum lipids, HSCRP, glutathione, and malondialdehyde levels in DN patients; however, it did not affect markers of insulin metabolism or biomarkers of inflammation and oxidative stress. [ABSTRACT FROM AUTHOR]

Introduction: This study evaluated the effects of nano-curcumin intake on metabolic status in patients with diabetes on hemodialysis (HD).Methods: This randomized, double-blind, placebo-controlled clinical trial was performed on 60 patients with diabetes on HD. Participants were randomly divided into two groups to take either 80 mg/d nano-curcumin (n = 30) or placebo (n = 30) for 12 weeks.Results: Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P < .05) when compared with patients who received placebo. Nanocurcumin treatment was associated with a significant reduction in triglycerides (β = -16.13 mg/dL, 95% CI: -31.51 to -0.75; P < .05), VLDL-cholesterol (β = -3.22 mg/dL, 95% CI: -6.30 to -0.15; P < .05), total cholesterol (β = -17.83 mg/dL, 95% CI: -29.22 to -6.45; P < .05), LDL-cholesterol (β = -15.20 mg/dL, 95% CI: -25.53 to -4.87; P < .05), and total-cholesterol/HDL-cholesterol ratio (β = -1.15, 95% CI: -0.2.10 to -0.21; P < .05) when compared with the placebo. Nanocurcumin also resulted in a significant reduction of serum high sensitivity CRP (β = -0.78 mg/L, 95% CI: -1.41 to -0.15; P < .05), and plasma malondialdehyde (β = -0.25 μmol/L, 95% CI: -0.45 to -0.04; P < .05); but also with a significant increase in plasma total antioxidant capacity (β = 52.43 mmol/L; 95% CI: 4.52 to 100.35; P < .05) and total nitrite levels (β = 3.62 μmol/L, 95% CI: 2.17 to 5.08; P < .001) when compared with placebo.Conclusion: Nano-curcumin intake for 12 weeks had beneficial effects on metabolic profile in patients with diabetes on HD. [ABSTRACT FROM AUTHOR]

Background: To the best of our knowledge, data on effects of probiotic administration on hormonal profiles, biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome (PCOS) are scarce. This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles, biomarkers of inflammation and oxidative stress in women with PCOS. Methods: This randomized, double-blind, placebo-controlled trial was conducted on 60 women with PCOS, aged 18-40 years old. Subjects were randomly assigned into 2 groups to receive either probiotics or placebo (n = 30 each group) for 12 weeks. Metabolic profiles were quantified at baseline and after a 12-week intervention. Results: After the 12-week intervention, compared with placebo, probiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (+25.9 ± 32.5 vs. +0.5 ± 15.6 nmol/L, P < 0.001) and plasma total antioxidant capacity (TAC) (+8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L, P = 0.04), and significantly decreased serum total testosterone (-0.2 ± 0.7 vs. +0.2 ± 0.6 ng/mL, P = 0.03), modified Ferriman-Gallwey (mF-G) scores (-1.7 ± 1.5 vs. -0.2 ± 1.0, P < 0.001), serum high-sensitivity C-reactive protein (hs-CRP) (-1150.0 ± 1295.2 vs. +202.5 ± 1426.3 ng/mL, P < 0.001) and plasma malondialdehyde (MDA) concentrations (-0.2 ± 0.6 vs. +0.9 ± 1.3 µmol/L, P < 0.001). We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles. Conclusion: Overall, probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone, SHBG, mFG scores, hs-CRP, TAC and MDA levels but did not affect other metabolic profiles. [ABSTRACT FROM AUTHOR]

We, the Editor and Publisher of the Journal of Psychosomatic Obstetrics & Gynecology have retracted the following article:Mehrdad Amini, Fereshteh Bahmani, Fatemeh Foroozanfard, Zahra Vahedpoor, Amir Ghaderi, Mohsen Taghizadeh, Hassan Karbassizadeh & Zatollah Asemi (2018), The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Journal of Psychosomatic Obstetrics & Gynecology , DOI: 10.1080/0167482X.2018.1508282.Following publication, significant concerns were raised by a third party 1 about the integrity of the data and the reported findings in the article.When approached for an explanation, the authors and their institution have been cooperative in providing some responses and documents. To verify the reported findings, the article and the documents provided by the authors were further evaluated by the journal editorial team, and also sent for review by an external statistical reviewer.Both the journal editorial team and the external statistical reviewer were unable to confirm the integrity of the trial design and the main outcome of the external review was that the article's results and conclusions are unreliable. Therefore, as the editorial team no longer have confidence in the reported conclusions the decision has been made to retract the article.The authors listed in the publication have been informed. The authors do not agree with the retraction.We have been informed in our decision-making by our editorial policies and the COPE guidelines.The retracted article will remain online to maintain the scholarly record, but it will be digitally watermarked on each page as 'Retracted'.

Background: Oxidative stress is involved in pathogenesis of some psychiatric disorders. To examine the role of oxidative stress in the etiopathogenesis of obsessive-compulsive disorder (OCD), we aimed to determine oxidative stress indices, including malondialdehyde (MDA) levels in serum and red blood cells (RBC) membrane, total antioxidant capacity (TAC), serum glutathione (GSH) levels, serum antioxidant vitamins (A and E), and Na + /K + -ATPase activity, in patients with the mentioned disorder vs. healthy controls., Method: 39 OCD patients diagnosed based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and 39 volunteer healthy subjects were included in this study. MDA levels in serum and RBC membrane were measured using fluorometric method. Serum TAC level, serum GSH level, and Na + /K + -ATPase activity were also measured using spectrophotometric methods. Serum levels of vitamins were calculated by reversed-phase high-performance liquid chromatography (RP-HPLC)., Result: There was a significantly higher MDA level in serum ( p < 0.0001) and RBC membrane ( p = 0.002) of OCD patients compared with those in controls. A significant reduction in vitamin A ( p = 0.001) and vitamin E ( p = 0.024) levels was found in OCD patients vs. controls. There was significantly lower activity of erythrocyte membrane Na + /K + -ATPase in RBC membrane of OCD patients vs. controls ( p < 0.0001)., Conclusion: Our findings indicate significantly higher levels MDA in both serum and RBC membrane, lower levels of serum vitamins A and E, and lower activity of membrane Na + /K + -ATPase in OCD patients compared to controls. These suggest an imbalance between oxidant and antioxidant factors in OCD patients that might play a fundamental role in the etiopathogenesis of OCD., Competing Interests: The authors had no conflicts of interest., (Copyright © 2024 Amir Hossein Mohammadi et al.)

There was inconsistent evidence showing that vitamin D intake may be associated with reduced cancer risk due to optimized metabolic profile and reduced oxidative stress. However, we are not aware of any study evaluating the effects of vitamin D supplementation on clinical response and metabolic status of patients with endometrial hyperplasia (EH). This research was done to evaluate the effects of vitamin D supplementation on clinical response and metabolic status of patients with EH. This randomized, double-blind, placebo-controlled trial was conducted among 60 women diagnosed with EH. EH diagnosis was made based on specific diagnostic procedures of biopsy. Participants were randomly assigned into two groups to intake either 50,000 IU vitamin D3 supplements (n = 30) or placebo (n = 30) every 2 weeks for 12 weeks. After the 12-week intervention, compared with the placebo, vitamin D supplementation increased serum-25(OH) vitamin D levels (+12.0 ± 10.4 vs. +1.9 ± 7.1 ng/mL, P < 0.001). In addition, vitamin D administration was associated with significant decreases in fasting plasma glucose (FPG) (-1.6 ± 7.0 vs. +2.1 ± 6.1 mg/dL, P = 0.03), serum insulin levels (-0.8 ± 1.9 vs. +1.1 ± 3.5 μIU/mL, P = 0.01), homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.2 ± 0.6 vs. +0.3 ± 0.8, P = 0.01), and a significant increase in the quantitative insulin sensitivity check index (QUICKI) (+0.003 ± 0.01 vs. -0.01 ± 0.02, P = 0.02) compared with the placebo. Additionally, a significant decrease in serum high-sensitivity C-reactive protein (hs-CRP) (-1.9 ± 2.8 vs. -0.003 ± 2.0 μg/mL, P = 0.003) and a significant rise in plasma total antioxidant capacity (TAC) values (+62.5 ± 53.5 vs. +7.5 ± 34.1 mmol/L, P < 0.001) were observed following supplementation with vitamin D compared with the placebo. In conclusion, vitamin D3 supplementation for 12 weeks among women with EH had beneficial effects on glucose metabolism, serum hs-CRP, and plasma TAC concentrations. In addition, vitamin D may have played an indirect role in reducing complications of EH due to its effect on improved glycemic control, hs-CRP, and TAC concentrations.

Objectives: Limited data are available for assessing the effects of omega-3 fatty acids and vitamin E co-supplementation on metabolic profiles and pregnancy outcomes in gestational diabetes (GDM). This study was designed to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on biomarkers of oxidative stress, inflammation and pregnancy outcomes in women with GDM., Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted in 60 patients with GDM who were not taking oral hypoglycemic agents. Patients were randomly allocated to intake either 1000 mg omega-3 fatty acids from flaxseed oil plus 400 IU vitamin E supplements (n=30) or placebo (n=30) for 6 weeks. Fasting blood samples were obtained from the women at the beginning of the study and after the 6-week intervention to quantify related markers., Results: After 6 weeks of intervention, omega-3 fatty acids and vitamin E co-supplementation, compared with the placebo, resulted in a significant rise in total antioxidant capacity (TAC) (+187.5±224.9 vs. -32.5±136.1 mmol/L; p<0.001); nitric oxide (NO) (+5.0±7.7 vs. -12.0±28.0 µmol/L; p=0.002) and a significant decrease in plasma malondialdehyde (MDA) concentrations (-0.1±0.9 vs. +0.6±1.4 µmol/L; p=0.03). Co-supplementation with omega-3 fatty acids and vitamin E showed no detectable changes in plasma glutathione and serum high-sensitivity C-reactive protein levels. Joint omega-3 fatty acids and vitamin E supplementation resulted in lower incidences of hyperbilirubinemia in newborns (10.3% vs. 33.3%; p=0.03)., Conclusions: Overall, omega-3 fatty acids and vitamin E co-supplementation for 6 weeks in women with GDM had beneficial effects on plasma TAC, MDA and NO and on the incidence of the newborns' hyperbilirubinemia., (Copyright © 2016 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.)

We are not aware of any study examining the effects of long term vitamin D administration on regression and metabolic status of patients with cervical intraepithelial neoplasia grade 1 (CIN1). This study was performed to evaluate the effects of long-term vitamin D administration on regression and metabolic status of patients with CIN1. This randomized, double-blind, placebo-controlled trial was performed among 58 women diagnosed with CIN1. CIN1 diagnosis was performed based on specific diagnostic procedures of biopsy, pathological diagnosis, and colposcopy. Patients were randomly allocated into two groups to take 50,000 IU vitamin D3 supplements (n = 29) or placebo (n = 29) every 2 weeks for 6 months. Fasting blood samples were taken at the beginning of the study and end-of-trial to measure related markers. After 6 months of vitamin D administration, greater percentage of women in the vitamin D group had regressed CIN1 (84.6 vs. 53.8%, P = 0.01) than those in the placebo group. Long-term vitamin D supplementation increased serum-25(OH) vitamin D levels in the intervention group compared to the placebo group (+12.3 ± 11.4 vs. -0.1 ± 3.7 ng/mL, P < 0.001). In addition, vitamin D intake led to significant decreases in serum insulin levels (-5.3 ± 7.3 vs. +2.4 ± 5.9 μIU/mL, P < 0.001), homeostasis model of assessment-insulin resistance (-1.2 ± 1.6 vs. +0.5 ± 1.2, P < 0.001), homeostatic model assessment-Beta cell function (P = 0.005) and a significant elevation in quantitative insulin sensitivity check index (+0.03 ± 0.04 vs. -0.007 ± 0.02, P < 0.001) compared with the placebo group. Additionally, significant increases in plasma nitric oxide (NO) (+15.5 ± 10.3 vs. +4.0 ± 13.4 μmol/L, P = 0.001), total antioxidant capacity (TAC) (P = 0.04), total glutathione (GSH) (+11.8 ± 153.5 vs. -294.2 ± 595.1 μmol/L, P = 0.01) and a significant reduction in plasma malondialdehyde (MDA) levels (-0.8 ± 1.0 vs. -0.03 ± 1.4 μmol/L, P = 0.03) were observed following the administration of vitamin D supplements compared with the placebo group. In conclusion, vitamin D3 administration for 6 months among women with CIN1 resulted in its regression and had beneficial effects on markers of insulin metabolism, plasma NO, TAC, GSH and MDA levels. Clinical trial registration number www.irct.ir : IRCT201412065623N30.

Background & Aims: This study was carried out to evaluate the effects of omega-3 fatty acid administration on markers of insulin resistance, lipid concentrations, biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy (DN)., Methods: This parallel randomized double-blind placebo-controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 1000 mg/day omega-3 fatty acid from flaxseed oil (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at the onset of the study and 12 weeks after supplementation to assess glycaemic status, lipid concentrations, biomarkers of inflammation and oxidative stress., Results: After 12 weeks of treatment, patients who consumed omega-3 fatty acid supplements compared with the placebo had significantly decreased serum insulin levels (-39.6 ± 10.8 vs. -7.2 ± 8.4 pmol/L, P = 0.001), homeostasis model of assessment-estimated b cell function (HOMA-B) (-30.2 ± 11.2 vs. -1.5 ± 6.8, P = 0.03) and improved quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.004 vs. +0.002 ± 0.004, P = 0.03). Additionally, compared with the placebo, omega-3 fatty acid administration led to a significant reduction in serum triglycerides (-19.8 ± 8.8 vs. +12.6 ± 10.2 mg/dL, P = 0.01) and VLDL-cholesterol concentrations (-4.0 ± 1.8 vs. +2.5 ± 2.0 mg/dL, P = 0.01). Supplementation with omega-3 fatty acid had no significant effects on other lipid subfractions, biomarkers of inflammation and oxidative stress compared with the placebo. In addition, within-group differences revealed significant reductions in serum insulin (P = 0.001), HOMA-IR (P = 0.004), HOMA-B (P = 0.01), serum triglycerides (P = 0.03), VLDL- (P = 0.03), total- (P < 0.001), LDL- (P = 0.002), total-/HDL-cholesterol ratio (P = 0.001), blood urea nitrogen (P = 0.04), and significant increases in QUICKI (P = 0.001) and nitric oxide (P = 0.005) and total antioxidant capacity concentrations (P = 0.02) in the omega-3 fatty acid group., Conclusions: Our findings indicated that omega-3 fatty acid administration for 12 weeks among DN patients had favorable effects on insulin levels, HOMA-B, QUICKI, serum triglycerides and VLDL-cholesterol; however, it did not influence biomarkers of inflammation and oxidative stress., (Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Objective: This study was conducted to determine the effects of long-term folate supplementation on regression and metabolic status of patients with cervical intraepithelial neoplasia grade 1 (CIN1)., Methods: This randomized, double-blind, placebo-controlled trial was performed among 58 women diagnosed with CIN1, ages 18 to 55 y old. Participants were randomly divided into two groups to receive 5 mg/d folate supplements (n = 29) or placebo (n = 29) for 6 mo. Fasting blood samples were taken at baseline and 6 mo after intervention to quantify related markers., Results: A greater percentage of women in the folate group had regressed CIN1 (83.3 versus 52.0%, P = 0.019) than those in the placebo group. Long-term folate supplementation resulted in a significant decrease in serum insulin levels (-1.6 ± 6.2 versus +2.6 ± 6.9 μIU/mL, P = 0.018) and homeostatic model assessment-beta cell function (HOMA-B) (-13.0 ± 39.0 versus +11.2 ± 42.3, P = 0.028) compared with the placebo. Additionally, plasma glutathione (GSH) levels were significantly increased (+81.5 ± 264.1 versus -220.9 ± 342.5 μmol/L, P < 0.001) and malondialdehyde (MDA) levels were significantly reduced (-1.0 ± 1.1 versus +0.1 ± 1.6 μmol/L, P = 0.004) in the folate group compared to the placebo., Conclusions: Taken together, folate supplementation (5 mg/d) for 6 mo among women with CIN1 resulted in its regression as well as led to decreased serum insulin, HOMA-B, plasma MDA and increased plasma GSH levels; however, it did not affect other metabolic profiles., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: This study was carried out to evaluate the effects of folate supplementation on carotid intima-media thickness (CIMT) and metabolic status among patients with metabolic syndrome (MetS)., Methods: This randomized, double-blind, placebo-controlled trial was conducted among 60 patients with type 2 diabetes mellitus and coronary heart disease. They were all overweight in the age range 40-85 years. Participants were randomly divided into 2 groups: group A (n = 30) received 5 mg folate supplements and group B (n = 30) received placebo for 12 weeks., Results: Folate supplementation resulted in a significant reduction in maximum levels of left CIMT (-0.05 ± 0.13 vs. +0.02 ± 0.11 mm, p = 0.01) compared with the placebo. Changes in fasting plasma glucose (-2.2 ± 37.5 vs. +30.2 ± 65.8 mg/dl, p = 0.02), serum insulin concentration (-2.0 ± 10.7 vs. +3.0 ± 7.6 µIU/ml, p = 0.04) and homeostasis of assessment-estimated insulin resistance (-0.6 ± 2.3 vs. +0.9 ± 2.3, p = 0.01) in supplemented patients were significantly different from those of patients in the placebo group. Changes in serum triglycerides (p = 0.04), high-density lipoprotein-cholesterol (p = 0.001), high sensitivity C-reactive protein (p = 0.01) and plasma nitric oxide concentrations (p < 0.001) were significantly different between the supplemented patients and placebo group., Conclusions: Overall, 5 mg/day folate supplementation for 12 weeks among patients with MetS had beneficial effects on CIMT and the metabolic status., (© 2016 S. Karger AG, Basel.)

Background & Aims: Few studies have examined the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations in overweight and obese vitamin D deficient women with polycystic ovary syndrome (PCOS). This study was conducted to determine the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations among overweight and obese vitamin D deficient women with PCOS., Methods: This randomized double-blind placebo-controlled clinical trial was conducted among 104 overweight and obese vitamin D deficient women diagnosed with PCOS. Participants were randomly assigned into four groups to receive: 1) 1000 mg/d calcium + vitamin D placebo (n = 26); 2) 50,000 IU/wk vitamin D + calcium placebo (n = 26); 3) 1000 mg calcium/d + 50,000 IU/wk vitamin D (n = 26) and 4) calcium placebo + vitamin D placebo (n = 26) for 8 weeks. Fasting blood samples were taken at baseline and after 8 weeks' intervention to measure glucose metabolism and lipid concentrations., Results: Calcium-vitamin D co-supplementation resulted in higher levels of serum calcium (P = 0.002) and vitamin D (P < 0.001) compared with other groups. Co-supplementation, compared with other groups, led to decreased serum insulin levels (P = 0.03), homeostasis model of assessment-insulin resistance (HOMA-IR) score (P = 0.04) and a significant rise in quantitative insulin sensitivity check index (QUICKI) (P = 0.001). Furthermore, a significant decrease in serum triglycerides (P = 0.02) and VLDL-cholesterol levels (P = 0.02) was seen following the administration of calcium plus vitamin D supplements compared with the other groups. Co-supplementation with calcium and vitamin D had no significant effects on FPG, total-, LDL-, HDL-, and non-HDL-cholesterol levels., Conclusions: In conclusion, calcium plus vitamin D supplementation for eight weeks among vitamin D deficient women with PCOS had beneficial effects on serum insulin levels, HOMA-IR, QUICKI, serum triglycerides and VLDL-cholesterol levels, but it did not affect FPG and other lipid profiles. Clinical registration numberwww.irct.ir: IRCT201309275623N10., (Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)