Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial

The BMJ
May 2011
Citations:117
Influential Citations:3
Interventional (Human) Studies
87
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Methods
Individually randomized, double-blind, placebo-controlled trial conducted at Safdarjung Hospital, New Delhi, India; 2,079 singleton term infants with birth weight 1.8–2.5 kg; enrolled within 48 hours of birth; followed to 6 months; informed consent obtained; exclusions included severe congenital abnormalities, severe illness before day 7, intention to move outside catchment area, or lack of consent.
Intervention
Vitamin D3, 35 µg (1400 IU) weekly for six months (up to 25 doses), starting at 7 days of age; taken by dissolving in expressed breast milk and administered at home by field workers.
Results
Vitamin D3 weekly 35 µg (1400 IU) for six months increased plasma calcidiol at six months (unadjusted difference 19.0 nmol/L; 95% CI 14.7–23.5; P<0.001; adjusted difference 18.7 nmol/L; 95% CI 14.2–23.5; P<0.001). It significantly raised weight-, length-, and arm circumference-for-age z scores and reduced the proportion with stunted growth (length-for-age z ≤ −2) or low arm circumference z scores. It did not reduce death or hospital admission (92/1039 vs 99/1040; adjusted rate ratio 0.93; 95% CI 0.68–1.29; P=0.68). Conclusion: A weekly vitamin D dose improved vitamin D status and bone growth but did not decrease mortality or severe morbidity in this population; higher doses or maternal supplementation may be needed to amplify health benefits.
Limitations
Large loss to follow-up and incomplete anthropometric data reduced power to detect differences in mortality and morbidity; observed event rates were lower than planned, requiring a larger sample to detect the intended 25% reduction (approx. 1500 per group); attrition biased toward poorer families and may affect generalizability.

Abstract

Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries. Design Randomised controlled trial. Setting Large government hospital in New Delhi, India. Partici...