Clinical trial NCT04270643: Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Official title: Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Acute Malnutrition
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University of the Punjab
name: University College, London
First posted: 2020-02-17
Enrollment: 259
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

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