CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 259 enrolled
Drug / intervention
Vitamin D3 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04270643
NCT04270643Phase 2Completed
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Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition

Queen Mary University of London·interventional·Posted Feb 17, 2020·Updated Jul 8, 2024

In Brief

A Phase 2 clinical trial evaluating Vitamin D3 and Placebo for Severe Acute Malnutrition. Completed, enrolled 259 participants across 2 sites.

Detailed Summary

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Acute Malnutrition
CountriesPakistan
CollaboratorsUniversity of the Punjab, University College, London

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartDec 2, 2021
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.4 years ago

Interventions

Vitamin D3dietary

ATC code A11CC05 (cholecalciferol)

Placebodietary

Ethyl oleate