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i. To examine the impact of malnutrition on development quotient of children
ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age.
iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUTF with Vitamin D | Experimental | Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose. |
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| RUTF with Placebo | Placebo Comparator | Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Two doses of Vitamin D supplementation in ampoules form (ED3) were procured. Ampoule contains Cholecalciferol in 200,000 IU both for oral and intra muscular use. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain in children | More than 15% weight gain from enrollment date | 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Developmental Milestones of children | Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2) | 2 Months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Z Zakar, PhD | University of the Punjab | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33305842 | Derived | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. | |
| 29722846 | Derived | Saleem J, Zakar R, Zakar MZ, Belay M, Rowe M, Timms PM, Scragg R, Martineau AR. High-dose vitamin D3 in the treatment of severe acute malnutrition: a multicenter double-blind randomized controlled trial. Am J Clin Nutr. 2018 May 1;107(5):725-733. doi: 10.1093/ajcn/nqy027. |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Ready to Use Therapeutic Food (RUTF) | Dietary Supplement | RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight. |
|