Trials / Completed
CompletedNCT04270643
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 259 (actual)
- Sponsor
- Queen Mary University of London · Academic / Other
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D3 | ATC code A11CC05 (cholecalciferol) |
| DIETARY_SUPPLEMENT | Placebo | Ethyl oleate |
Timeline
- Start date
- 2021-12-02
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
- First posted
- 2020-02-17
- Last updated
- 2024-07-08
Locations
2 sites across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT04270643. Inclusion in this directory is not an endorsement.