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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2024-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Severe Acute Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Two oral doses of 5 mg (200,000 international units) vitamin D3 in 1 ml ethyl oleate, given at baseline and two weeks thereafter

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

ATC code A11CC05 (cholecalciferol)

Placebo

Two oral doses of 1 ml ethyl oleate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Ethyl oleate

Interventions

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Vitamin D3

ATC code A11CC05 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Ethyl oleate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Consent of parent / guardian
* Age 6-59 months at enrolment
* Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation.
* Medical team managing the child has made the decision to discharge the child from inpatient care

Exclusion Criteria

* Ingestion of a dose of vitamin D\>200,000 IU (5 mg) in the last 3 months
* Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
* Known neurodevelopmental disorder (e.g. cerebral palsy)
* HIV infection
* Taking anti-tuberculosis treatment
* Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
* Signs of rickets
* Corrected serum calcium concentration \>2.65 mmol/L on blood sample taken during the current hospital admission

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No