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Am J Clin Nutr. 2018 May 1;107(5):725-733. doi: 10.1093/ajcn/nqy027.

High-dose vitamin D3 in the treatment of severe acute malnutrition: a multicenter double-blind randomized controlled trial.

Author information

1
Department of Public Health, Institute of Social and Cultural Studies, University of the Punjab, Lahore, Pakistan.
2
Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
3
Department of Clinical Biochemistry, Homerton University Hospital, London, United Kingdom.
4
School of Population Health, University of Auckland, Auckland, New Zealand.

Abstract

Background:

Vitamin D deficiency is common in children with severe acute malnutrition, in whom it is associated with severe wasting. Ready-to-use therapeutic food (the standard treatment) contains modest amounts of vitamin D that do not reliably correct deficiency.

Objective:

The aim of this study was to determine whether high-dose oral vitamin D3 enhances weight gain and development in children with uncomplicated severe acute malnutrition.

Design:

We conducted a randomized placebo-controlled trial of high-dose vitamin D3 supplementation in children aged 6-58 mo with uncomplicated severe acute malnutrition in Pakistan. Participants were randomly assigned to receive 2 oral doses of 200,000 IU vitamin D3 or placebo at 2 and 4 wk after starting ready-to-use therapeutic food. The primary outcome was the proportion of participants gaining >15% of baseline weight at 8 wk after starting ready-to-use therapeutic food (the end of the study). Secondary outcomes were mean weight-for-height or -length z score and the proportion of participants with delayed development at the end of the study (assessed with the Denver Development Screening Tool II), adjusted for baseline values.

Results:

Of the 194 randomly assigned children who started the study, 185 completed the follow-up and were included in the analysis (93 assigned to intervention, 92 to control). High-dose vitamin D3 did not influence the proportion of children gaining >15% of baseline weight at the end of the study (RR: 1.04; 95% CI: 0.94,1.15, P = 0.47), but it did increase the weight-for-height or -length z score (adjusted mean difference: 1.07; 95% CI: 0.49,1.65, P < 0.001) and reduce the proportion of participants with delayed global development [adjusted RR (aRR): 0.49; 95% CI: 0.31, 0.77, P = 0.002], delayed gross motor development (aRR: 0.29; 95% CI: 0.13, 0.64, P = 0.002), delayed fine motor development (aRR: 0.59; 95% CI: 0.38, 0.91, P = 0.018), and delayed language development (aRR: 0.57; 95% CI: 0.34, 0.96, P = 0.036).

Conclusions:

High-dose vitamin D3 improved the mean weight-for-height or -length z score and developmental indexes in children receiving standard therapy for uncomplicated severe acute malnutrition in Pakistan. This trial was registered at clinicaltrials.gov as NCT03170479.

PMID:
29722846
DOI:
10.1093/ajcn/nqy027

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