Project Details

E.W. "Al" Thrasher

Status: Funded - Open

Trial of high-dose vitamin D in the treatment of complicated severe acute malnutrition (ViDiSAM)

Adrian Martineau, MRCP, PhD, FRSB

Summary

BACKGROUND: Severe acute malnutrition (SAM) is the most extreme and visible form of undernutrition. It is classified as ‘complicated’ when it is accompanied by a severe infection, other systemic illness or lack of appetite, meaning that children cannot be safely managed in a community setting and therefore require hospitalization for nutritional rehabilitation. GAP: We have previously conducted a randomized controlled trial in Pakistan showing that high-dose vitamin D supplementation improves weight gain and neurodevelopment in children with uncomplicated SAM. We now want to find out whether this intervention can also benefit children with complicated SAM – who experience the worst outcomes. HYPOTHESIS: We hypothesize that administration of high-dose oral vitamin D supplementation to children who are recovering from complicated SAM will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes, efficacy). METHODS: We will conduct a multi-center double-blind randomized placebo-controlled trial with two parallel arms and 6-month follow-up in 250 children who were originally hospitalized for treatment of complicated SAM at two sites in Lahore, Pakistan, and who are now ready for hospital discharge. RESULTS: Pending IMPACT: If this trial yields positive results, this inexpensive intervention could readily be incorporated into treatment regimens for complicated SAM. Website Link: https://clinicaltrials.gov/ct2/show/NCT04270643