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.
BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975.
Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S.
Institute of Home Economics, Delhi University, F-4 Haus Khas Enclave. New Delhi-110016, India.
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.
PARTICIPANTS: 2079 low birthweight infants born at term (>37 weeks' gestation).
MAIN OUTCOME MEASURES: Primary outcome was admission to hospital or death during the first six months of life. Main secondary outcome was growth.
INTERVENTIONS: Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day (35 µg/week). Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements.
RESULTS: Between group differences were not significant for death or hospital admissions (92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group; adjusted rate ratio 0.93, 95% confidence interval 0.68 to 1.29; P=0.68), or referral to the outpatient clinic for moderate morbidity.
Vitamin D supplementation resulted in better vitamin D status as assessed by plasma calcidiol levels at six months. In adjusted analyses, vitamin D treatment significantly increased standard deviation (z) scores at six months for
- length, and
- arm circumference and
- decreased the proportion of children with stunted growth (length for age z score ?2) or with
- (decreased) arm circumference z scores of 2 or less.
CONCLUSION: A weekly dose of vitamin D resulted in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants.
Trial registration ClinicalTrials.gov NCT00415402. PMID: 21628364
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