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

Severe Acute Malnutrition Clinical Trial

— ViDiSAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04270643
• Other study ID #: ViDiSAM
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 27, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 259
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• Vitamin D3
ATC code A11CC05 (cholecalciferol)
• Placebo
Ethyl oleate

Locations

Country	Name	City	State
Pakistan	Sir Ganga Ram Hospital	Lahore
Pakistan	THQ Hospital	Lahore

Sponsors (3)

Lead Sponsor	Collaborator
Queen Mary University of London	University College, London, University of the Punjab

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean weight-for-height/length z-score		2 months
Secondary	Mean weight-for-height/length z-score		6 months
Secondary	Mean weight-for-age z-score		2 and 6 months
Secondary	Mean height/length-for-age z-score		2 and 6 months
Secondary	Mean head circumference-for-age z-score		2 and 6 months
Secondary	Mean mid-upper arm circumference		2 and 6 months
Secondary	Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool		2 and 6 months
Secondary	Mean fat mass index		2 and 6 months
Secondary	Mean fat-free mass index		2 and 6 months
Secondary	Proportion of participants experiencing relapse of severe acute malnutrition		6 months
Secondary	Proportion of participants readmitted to hospital due to any cause		6 months
Secondary	Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)		2 and 6 months
Secondary	Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin		2 and 6 months
Secondary	Mean haemoglobin concentration, full blood count		2 and 6 months
Secondary	Mean corpuscular volume, full blood count		2 and 6 months
Secondary	Mean corpuscular haemoglobin concentration, full blood count		2 and 6 months
Secondary	Mean neutrophil count, full blood count		2 and 6 months
Secondary	Mean lymphocyte count, full blood count		2 and 6 months
Secondary	Mean monocyte count, full blood count		2 and 6 months
Secondary	Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)		2 and 6 months
Secondary	Faecal microbiome composition		2 and 6 months
Secondary	Proportion of participants dying		6 months
Secondary	Incidence of serious adverse events		6 months
Secondary	Incidence of adverse reactions		6 months