1. Effect of Daily Vitamin D Supplementation on Risk of Upper Respiratory Infection in Older Adults: A Randomized Controlled Trial.
- Author
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Camargo, Carlos A, Schaumberg, Debra A, Friedenberg, Georgina, Dushkes, Rimma, Glynn, Robert J, Gold, Diane R, Mora, Samia, Lee, I Min, Buring, Julie E, and Manson, JoAnn E
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RISK assessment , *SELF-evaluation , *REPEATED measures design , *RESPIRATORY infections , *PLACEBOS , *DATA analysis , *RESEARCH funding , *STATISTICAL sampling , *BLIND experiment , *HUMAN research subjects , *LOGISTIC regression analysis , *RANDOMIZED controlled trials , *DESCRIPTIVE statistics , *CHOLECALCIFEROL , *ODDS ratio , *INFORMED consent (Medical law) , *STATISTICS , *HEALTH outcome assessment , *CONFIDENCE intervals , *DATA analysis software , *VITAMIN D , *DIETARY supplements , *DISEASE risk factors , *OLD age - Abstract
Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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