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Background: There is strong mechanistic evidence to suggest that vitamin D and omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFAs), specifically docosahexaenoic acid (DHA), have the potential to significantly improve the symptoms of autism spectrum disorder (ASD). However, there are no trials that have measured the effect of both vitamin D and n-3 LCPUFA supplementation on autism severity symptoms. The objective of this 2 × 2 factorial trial is to investigate the effect of vitamin D, n-3 LCPUFAs or a combination of both on core symptoms of ASD.Methods/design: Children with ASD living in New Zealand (n = 168 children) will be randomised to one of four treatments daily: vitamin D (2000 IU), n-3 LCPUFAs (722 mg DHA), vitamin D (2000 IU) + n-3 LCPUFAs (722 mg DHA) or placebo for 12 months. All researchers, participants and their caregivers will be blinded until the data analysis is completed, and randomisation of the active/placebo capsules and allocation will be fully concealed from all mentioned parties. The primary outcome measures are the change in social-communicative functioning, sensory processing issues and problem behaviours between baseline and 12 months. A secondary outcome measure is the effect on gastrointestinal symptoms. Baseline data will be used to assess and correct basic nutritional deficiencies prior to treatment allocation. For safety measures, serum 25-hydroxyvitamin D 25(OH)D and calcium will be monitored at baseline, 6 and 12 months, and weekly compliance and gastrointestinal symptom diaries will be completed by caregivers throughout the study period.Discussion: To our knowledge there are no randomised controlled trials assessing the effects of both vitamin D and DHA supplementation on core symptoms of ASD. If it is shown that either vitamin D, DHA or both are effective, the trial would reveal a non-invasive approach to managing ASD symptoms.Trial Registration: Australian New Zealand Clinical Trial Registry, ACTRN12615000144516 . Registered on 16 February 2015. [ABSTRACT FROM AUTHOR]

Background: Preterm birth and very small size at birth have long-term effects on neurodevelopment and growth. A relatively small percentage of extremely low birthweight babies suffer from severe neurological disability; however, up to 50% experience some neurodevelopmental or learning disability in childhood. Current international consensus is that increased protein intake in the neonatal period improves both neurodevelopment and growth, but the quantum of protein required is not known. This trial aims to assess whether providing an extra 1 to 2 g.kg-1.d-1 protein in the first 5 days after birth will improve neurodevelopmental outcomes and growth in extremely low birthweight babies. Methods/Design: The ProVIDe study is a multicentre, two-arm, double-blind, parallel, randomised, controlled trial. In addition to standard intravenous nutrition, 430 babies with a birthweight of less than 1000 g who have an umbilical arterial line in situ will be randomised in 1:1 ratio to receive either an amino acid solution (TrophAmine®) or placebo (saline) administered through the umbilical arterial catheter for the first 5 days. Exclusion criteria are admission to neonatal intensive care more than 24 h after birth; multiple births of more than 2 babies; known chromosomal or genetic abnormality, or congenital disorder affecting growth; inborn error of metabolism, and in danger of imminent death. Primary outcome: Survival free from neurodevelopmental disability at 2 years' corrected age, where neurodevelopmental disability is defined as cerebral palsy, blindness, deafness, developmental delay (standardised score more than 1 SD below the mean on the cognitive, language or motor subscales of the Bayley Scales of Infant Development Edition 3), or Gross Motor Function Classification System score =1. Secondary outcomes: Growth, from birth to 36 weeks' corrected gestational age, at neonatal intensive care discharge and at 2 years' corrected age; body composition at 36 to 42 weeks' corrected postmenstrual age and at 2 years' corrected age; neonatal morbidity, including length of stay; nutritional intake. Discussion: This trial will provide the first direct evidence of the effects of giving preterm babies a higher intake of intravenous protein in the first week after birth on neurodevelopmental outcomes at 2 years corrected age. [ABSTRACT FROM AUTHOR]

Background: Dietary treatment is often recommended as the first line of treatment for women with mild iron deficiency. Although it is well established that ascorbic acid enhances iron absorption, it is less clear whether the consumption of ascorbic acid rich foods (such as kiwifruit) with meals fortified with iron improves iron status. The aim of this study is to investigate whether the consumption of ZESPRI® GOLD kiwifruit (a fruit high in ascorbic acid and carotenoids) with an iron fortified breakfast cereal meal increases iron status in women with low iron stores. Methods/Design: Eighty nine healthy women aged 18-44 years with low iron stores (serum ferritin (SF) ⩽ 25 μg/L, haemoglobin (Hb) ⩾ 115 g/L) living in Auckland, New Zealand were randomised to receive an iron fortified breakfast cereal (16 mg iron per serve) and either two ZESPRI® GOLD kiwifruit or a banana (low ascorbic acid and carotenoid content) to eat at breakfast time every day for 16 weeks. Iron status (SF, Hb, C-reactive protein (CRP) and soluble transferrin receptor (sTfR)), ascorbic acid and carotenoid status were measured at baseline and after 16 weeks. Anthropometric measures, dietary intake, physical activity and blood loss were measured before and after the 16 week intervention. Discussion: This randomised controlled intervention study will be the first study to investigate the effect of a dietary based intervention of an iron fortified breakfast cereal meal combined with an ascorbic acid and carotenoid rich fruit on improving iron status in women with low iron stores. [ABSTRACT FROM AUTHOR]

Background: The identification of the vitamin D receptor in the endocrine pancreas suggests a role for vitamin D in insulin secretion. There is also some limited evidence that vitamin D influences insulin resistance, and thus the early stages of the development of type 2 diabetes.Methods: Eighty-four women of South Asian origin, living in Auckland, New Zealand, were randomised to receive either a supplement (4000IU 25(OH)D3 per day) or a placebo for 6 months. At baseline, all participants were vitamin D deficient (serum 25(OH)D3 <50 nmol/L), insulin resistant (HOMA-IR > 1.93) and/or hyperinsulinaemic, hyperglycemic or had clinical signs of dislipidaemia. Changes in HOMA-IR, lipids, parathyroid hormone, calcium and bone markers were monitored at 3 months and 6 months.Discussion: This randomised, controlled trial will be the first to investigate the effect of vitamin D supplementation on insulin resistance in non-diabetic subjects. It will subsequently contribute to the growing body of evidence about the role of vitamin D in metabolic syndrome. Registered clinical.Trial Registration: Registered clinical trial--Registration No. ACTRN12607000642482. [ABSTRACT FROM AUTHOR]