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| Name | Class |
|---|---|
| University of the Punjab | OTHER |
| University College, London | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | 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 Comparator | Two oral doses of 1 ml ethyl oleate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | ATC code A11CC05 (cholecalciferol) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean weight-for-height/length z-score | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean weight-for-height/length z-score | 6 months | |
| Mean weight-for-age z-score | 2 and 6 months | |
| Mean height/length-for-age z-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Ganga Ram Hospital | Lahore | Pakistan | ||||
| THQ Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40089464 | Derived | Saleem J, Zakar R, Butt MS, Kaleem R, Chaudhary A, Chandna J, Jolliffe DA, Piper J, Abbas Z, Tang JCY, Fraser WD, Freemantle N, Prendergast AJ, Martineau AR. High-dose vitamin D3 to improve outcomes in the convalescent phase of complicated severe acute malnutrition in Pakistan: a double-blind randomised controlled trial (ViDiSAM). Nat Commun. 2025 Mar 15;16(1):2554. doi: 10.1038/s41467-025-57803-9. |
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De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
2 years after completion of the trial
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2026 | |
| Reset | Mar 18, 2026 | |
| Release | Jun 12, 2026 | |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2026 | Mar 18, 2026 | |||
| Jun 12, 2026 |
| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Dietary Supplement |
Ethyl oleate |
|
| 2 and 6 months |
| Mean head circumference-for-age z-score | 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 fat mass index | 2 and 6 months |
| Mean fat-free mass index | 2 and 6 months |
| Proportion of participants experiencing relapse of severe acute malnutrition | 6 months |
| Proportion of participants readmitted to hospital due to any cause | 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 |
| Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin | 2 and 6 months |
| Mean haemoglobin concentration, full blood count | 2 and 6 months |
| Mean corpuscular volume, full blood count | 2 and 6 months |
| 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 monocyte count, full blood count | 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 |
| Proportion of participants dying | 6 months |
| Incidence of serious adverse events | 6 months |
| Incidence of adverse reactions | 6 months |
| Lahore |
| Pakistan |
| Jul 9, 2026 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |