Trial | NCT00415402  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    2000
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 Started
Mar 31
2007
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Aug 22
2012
Estimate

Drug Vitamin D3

placebo Placebo Comparator

non vitamin D containing sugar granules

Vitamin D3 Experimental

vitamin D granules

Criteria 

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
No Results Posted