Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at term, as determined from last menstrual period Weighing < 2.5 kg Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months With no severe congenital abnormalities No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc. Parental informed consent

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>non vitamin D containing sugar granules | |
| Experimental: Vitamin D3<br>vitamin D granules | Drug: Vitamin D3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | weekly | 
| Incidence of disease requiring hospitalization |  |  | 
| Morbidity and hospitalization |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infectious disease not requiring hospitalization |  |  | 
| Severe morbidity requiring hospitalization |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D3, morbidity, mortality, low birth weight, supplementation, TH1, TH2, CRP, Neopterin, immune response