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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04270643
Other study ID # ViDiSAM
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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