Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Phase 2
Completed
- Conditions
- Severe Acute Malnutrition
- Interventions
- Dietary Supplement: Vitamin D3Dietary Supplement: Placebo
- Registration Number
- NCT04270643
- Lead Sponsor
- Queen Mary University of London
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Vitamin D3 Two oral doses of 5 mg (200,000 international units) vitamin D3 in 1 ml ethyl oleate, given at baseline and two weeks thereafter Placebo Placebo Two oral doses of 1 ml ethyl oleate
- Primary Outcome Measures
Name Time Method Mean weight-for-height/length z-score 2 months
- Secondary Outcome Measures
Name Time Method Mean corpuscular haemoglobin concentration, full blood count 2 and 6 months Mean neutrophil count, full blood count 2 and 6 months Mean lymphocyte count, full blood count 2 and 6 months Mean mid-upper arm circumference 2 and 6 months Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool 2 and 6 months Mean height/length-for-age z-score 2 and 6 months Mean corpuscular volume, full blood count 2 and 6 months Mean head circumference-for-age z-score 2 and 6 months Mean fat-free mass index 2 and 6 months Proportion of participants readmitted to hospital due to any cause 6 months Mean weight-for-height/length z-score 6 months Mean fat mass index 2 and 6 months Proportion of participants experiencing relapse of severe acute malnutrition 6 months Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin 2 and 6 months Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin) 2 and 6 months Faecal microbiome composition 2 and 6 months Incidence of serious adverse events 6 months Incidence of adverse reactions 6 months Mean weight-for-age z-score 2 and 6 months 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 Mean haemoglobin concentration, full blood count 2 and 6 months Proportion of participants dying 6 months Mean monocyte count, full blood count 2 and 6 months
Trial Locations
- Locations (2)
Sir Ganga Ram Hospital
🇵🇰Lahore, Pakistan
THQ Hospital
🇵🇰Lahore, Pakistan