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

Queen Mary University of London

Status and phase: Completed; Phase 2

Conditions: Severe Acute Malnutrition

Treatments: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04270643

ViDiSAM

Details and patient eligibility

About

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).

Enrollment: 259 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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259 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Two oral doses of 1 ml ethyl oleate

Treatment:

Dietary Supplement: Placebo