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

History of Changes

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:

MedlinePlus related topics: Birth Weight Dietary Supplements Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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

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:

Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. 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. BMJ. 2011 May 31;342:d2975.

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:

Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol

Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013

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