Back to resultsTrial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition (ViDiSAM)
Primary Purpose
Severe Acute Malnutrition
Status
Active
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Malnutrition
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
Sites / Locations
- Sir Ganga Ram Hospital
- THQ Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Two oral doses of 5 mg (200,000 international units) vitamin D3 in 1 ml ethyl oleate, given at baseline and two weeks thereafter
Two oral doses of 1 ml ethyl oleate
Outcomes
Primary Outcome Measures
Mean weight-for-height/length z-score
Secondary Outcome Measures
Mean weight-for-height/length z-score
Mean weight-for-age z-score
Mean height/length-for-age z-score
Mean head circumference-for-age z-score
Mean mid-upper arm circumference
Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool
Mean fat mass index
Mean fat-free mass index
Proportion of participants experiencing relapse of severe acute malnutrition
Proportion of participants readmitted to hospital due to any cause
Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)
Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin
Mean haemoglobin concentration, full blood count
Mean corpuscular volume, full blood count
Mean corpuscular haemoglobin concentration, full blood count
Mean neutrophil count, full blood count
Mean lymphocyte count, full blood count
Mean monocyte count, full blood count
Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)
Faecal microbiome composition
Proportion of participants dying
Incidence of serious adverse events
Incidence of adverse reactions
Full Information
NCT ID
NCT04270643
First Posted
February 7, 2020
Last Updated
March 8, 2023
Sponsor
Queen Mary University of London
Collaborators
University of the Punjab, University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04270643
Brief Title
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Acronym
ViDiSAM
Official Title
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
University of the Punjab, University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Two oral doses of 5 mg (200,000 international units) vitamin D3 in 1 ml ethyl oleate, given at baseline and two weeks thereafter
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two oral doses of 1 ml ethyl oleate
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
ATC code A11CC05 (cholecalciferol)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Ethyl oleate
Primary Outcome Measure Information:
Title
Mean weight-for-height/length z-score
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Mean weight-for-height/length z-score
Time Frame
6 months
Title
Mean weight-for-age z-score
Time Frame
2 and 6 months
Title
Mean height/length-for-age z-score
Time Frame
2 and 6 months
Title
Mean head circumference-for-age z-score
Time Frame
2 and 6 months
Title
Mean mid-upper arm circumference
Time Frame
2 and 6 months
Title
Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool
Time Frame
2 and 6 months
Title
Mean fat mass index
Time Frame
2 and 6 months
Title
Mean fat-free mass index
Time Frame
2 and 6 months
Title
Proportion of participants experiencing relapse of severe acute malnutrition
Time Frame
6 months
Title
Proportion of participants readmitted to hospital due to any cause
Time Frame
6 months
Title
Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)
Time Frame
2 and 6 months
Title
Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin
Time Frame
2 and 6 months
Title
Mean haemoglobin concentration, full blood count
Time Frame
2 and 6 months
Title
Mean corpuscular volume, full blood count
Time Frame
2 and 6 months
Title
Mean corpuscular haemoglobin concentration, full blood count
Time Frame
2 and 6 months
Title
Mean neutrophil count, full blood count
Time Frame
2 and 6 months
Title
Mean lymphocyte count, full blood count
Time Frame
2 and 6 months
Title
Mean monocyte count, full blood count
Time Frame
2 and 6 months
Title
Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)
Time Frame
2 and 6 months
Title
Faecal microbiome composition
Time Frame
2 and 6 months
Title
Proportion of participants dying
Time Frame
6 months
Title
Incidence of serious adverse events
Time Frame
6 months
Title
Incidence of adverse reactions
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sir Ganga Ram Hospital
City
Lahore
Country
Pakistan
Facility Name
THQ Hospital
City
Lahore
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
IPD Sharing Time Frame
2 years after completion of the trial
Learn more about this trial
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition
We'll reach out to this number within 24 hrs