Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants (DIVIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415402
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : August 22, 2012
London School of Hygiene and Tropical Medicine
Sitaram Bhartia Institute of Science and Research
Information provided by (Responsible Party):
Dr Geeta Trilok-Kumar, Delhi University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D3 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : March 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo
non vitamin D containing sugar granules
Experimental: Vitamin D3
vitamin D granules
Drug: Vitamin D3

Primary Outcome Measures :
  1. Mortality [ Time Frame: weekly ]
  2. Incidence of disease requiring hospitalization
  3. Morbidity and hospitalization [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. Incidence of infectious disease not requiring hospitalization
  2. Severe morbidity requiring hospitalization

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415402

Institute of Home Economics, Delhi University
New Delhi, India, 110016
Sponsors and Collaborators
Delhi University
London School of Hygiene and Tropical Medicine
Sitaram Bhartia Institute of Science and Research
Principal Investigator: Geeta Trilok-Kumar, PhD Institute of Home Economics, Delhi University

Publications of Results:
Responsible Party: Dr Geeta Trilok-Kumar, Associate professor, Delhi University Identifier: NCT00415402     History of Changes
Other Study ID Numbers: BT/PR 7489/PID/20/285/2006
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Dr Geeta Trilok-Kumar, Delhi University:
Vitamin D3
low birth weight
immune response

Additional relevant MeSH terms:
Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents