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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00415402
First received: December 21, 2006
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention
Vitamin D Deficiency
Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Delhi University:

Primary Outcome Measures:
  • Mortality [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • Incidence of disease requiring hospitalization
  • Morbidity and hospitalization [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of infectious disease not requiring hospitalization [ Designated as safety issue: No ]
  • Severe morbidity requiring hospitalization [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: March 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
non vitamin D containing sugar granules
Experimental: Vitamin D3
vitamin D granules
Drug: Vitamin D3

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.

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415402

Locations
India
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
Investigators
Principal Investigator: Geeta Trilok-Kumar, PhD Institute of Home Economics, Delhi University
  More Information

Publications:
Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Geeta Trilok-Kumar, Associate professor, Delhi University
ClinicalTrials.gov Identifier: NCT00415402     History of Changes
Other Study ID Numbers: BT/PR 7489/PID/20/285/2006, IHE/VITD/2006
Study First Received: December 21, 2006
Last Updated: August 21, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Delhi University:
Vitamin D3
morbidity
mortality
low birth weight
supplementation
TH1
TH2
CRP
Neopterin
immune response

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014