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Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition

NCT04270643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2024-07-08

No results posted yet for this study

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

  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

ATC code A11CC05 (cholecalciferol)

DIETARY_SUPPLEMENT

Placebo

Ethyl oleate

Sponsors & Collaborators

  • University of the Punjab

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270643 on ClinicalTrials.gov