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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00415402
Acronym
DIVIDS
Enrollment
2000
Registered
2006-12-22
Start date
2007-03-31
Completion date
2010-07-31
Last updated
2012-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D3, morbidity, mortality, low birth weight, supplementation, TH1, TH2, CRP, Neopterin, immune response

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.

Interventions

DRUGVitamin D3

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Sitaram Bhartia Institute of Science and Research
CollaboratorOTHER
Delhi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
24 Hours to 2 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Mortalityweekly
Incidence of disease requiring hospitalization
Morbidity and hospitalizationweekly

Secondary

MeasureTime frame
Incidence of infectious disease not requiring hospitalization
Severe morbidity requiring hospitalization

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026