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

NCT04270643 | Completed Phase 2 DMC

• 1 other identifier: ViDiSAM
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean weight-for-height/length z-score

  2 months

Secondary Outcomes (23)

• Mean weight-for-height/length z-score

  6 months

• Mean weight-for-age z-score

  2 and 6 months

• Mean height/length-for-age z-score

  2 and 6 months

• Mean head circumference-for-age z-score

  2 and 6 months

• Mean mid-upper arm circumference

  2 and 6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Two oral doses of 1 ml ethyl oleate

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

ATC code A11CC05 (cholecalciferol)

Vitamin D

Placebo DIETARY_SUPPLEMENT

Ethyl oleate

Placebo

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• University of the Punjab: collaborator
• University College, London: collaborator

Study Sites (2)

Sir Ganga Ram Hospital

Lahore, Pakistan

Location

THQ Hospital

Lahore, Pakistan

Location

Related Publications (1)

• Saleem J, Zakar R, Butt MS, Kaleem R, Chaudhary A, Chandna J, Jolliffe DA, Piper J, Abbas Z, Tang JCY, Fraser WD, Freemantle N, Prendergast AJ, Martineau AR. High-dose vitamin D3 to improve outcomes in the convalescent phase of complicated severe acute malnutrition in Pakistan: a double-blind randomised controlled trial (ViDiSAM). Nat Commun. 2025 Mar 15;16(1):2554. doi: 10.1038/s41467-025-57803-9.

  PMID: 40089464 DERIVED

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 17, 2020
• Study Start: December 2, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 2 years after completion of the trial

Locations

PA (2)