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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,000
Institute of Home Economics, Delhi University
New Delhi, India
Mortality
Time frame: weekly
Incidence of disease requiring hospitalization
Morbidity and hospitalization
Time frame: weekly
Incidence of infectious disease not requiring hospitalization
Severe morbidity requiring hospitalization
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