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

  • End date
    Oct 21, 2023
  • participants needed
  • sponsor
    Queen Mary University of London
Updated on 21 March 2022


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).

Condition Severe Acute Malnutrition
Treatment Placebo, Vitamin D3
Clinical Study IdentifierNCT04270643
SponsorQueen Mary University of London
Last Modified on21 March 2022


Yes No Not Sure

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
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