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| ID | Type | Description | Link |
|---|---|---|---|
| IHE/VITD/2006 |
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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| Sitaram Bhartia Institute of Science and Research | OTHER |
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The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.
We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | non vitamin D containing sugar granules | |
| Vitamin D3 | Experimental | vitamin D granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | weekly | |
| Incidence of disease requiring hospitalization | ||
| Morbidity and hospitalization | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infectious disease not requiring hospitalization | ||
| Severe morbidity requiring hospitalization |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geeta Trilok-Kumar, PhD | Institute of Home Economics, Delhi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Home Economics, Delhi University | New Delhi | 110016 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21628364 | Result | Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975. | |
| 22510791 | Result | Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |