Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00415402
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
2006-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants
Sponsor:
Delhi University
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVIDS
Brief Summary:
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:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IHE/VITD/2006 | None | None | View |