Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants

Vitamin D Deficiency Clinical Trial

— DIVIDS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415402
• Other study ID #: BT/PR 7489/PID/20/285/2006
• Secondary ID: IHE/VITD/2006
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: August 21, 2012
• Start date: March 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2012
• Source: Delhi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3

Locations

Country	Name	City	State
India	Institute of Home Economics, Delhi University	New Delhi

Sponsors (3)

Lead Sponsor	Collaborator
Delhi University	London School of Hygiene and Tropical Medicine, Sitaram Bhartia Institute of Science and Research

Country where clinical trial is conducted

India, 

References & Publications (2)

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 — View Citation

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 Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		weekly	Yes
Primary	Incidence of disease requiring hospitalization
Primary	Morbidity and hospitalization		weekly	Yes
Secondary	Incidence of infectious disease not requiring hospitalization			No
Secondary	Severe morbidity requiring hospitalization			No