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

Queen Mary University of London259 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

259

Conditions

Severe Acute Malnutrition

Interventions

Vitamin D3DIETARY_SUPPLEMENT

ATC code A11CC05 (cholecalciferol)

PlaceboDIETARY_SUPPLEMENT

Ethyl oleate

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (2)

Sir Ganga Ram Hospital

Lahore, Pakistan

THQ Hospital

Lahore, Pakistan

Outcomes

Primary Outcomes

Mean weight-for-height/length z-score

Time frame: 2 months

Secondary Outcomes

Mean weight-for-height/length z-score

Time frame: 6 months

Mean weight-for-age z-score

Time frame: 2 and 6 months

Mean height/length-for-age z-score

Time frame: 2 and 6 months

Mean head circumference-for-age z-score

Time frame: 2 and 6 months

Mean mid-upper arm circumference

Time frame: 2 and 6 months

Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool

Time frame: 2 and 6 months

Mean fat mass index

Time frame: 2 and 6 months

Mean fat-free mass index

Time frame: 2 and 6 months

Proportion of participants experiencing relapse of severe acute malnutrition

Time frame: 6 months

Proportion of participants readmitted to hospital due to any cause

Time frame: 6 months

Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)

Data from ClinicalTrials.gov

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