Status:
COMPLETED
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
University of the Punjab
University College, London
Conditions:
Severe Acute Malnutrition
Eligibility:
All Genders
6-5 years
Phase:
PHASE2
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 recov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04270643
Start Date
December 2 2021
End Date
June 30 2024
Last Update
July 8 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sir Ganga Ram Hospital
Lahore, Pakistan
2
THQ Hospital
Lahore, Pakistan