Status:

COMPLETED

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

Lead Sponsor:

Delhi University

Collaborating Sponsors:

London School of Hygiene and Tropical Medicine

Sitaram Bhartia Institute of Science and Research

Conditions:

Vitamin D Deficiency

Eligibility:

All Genders

24-2 years

Phase:

NA

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 po...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2010

    Estimated Enrollment :

    2000 Patients enrolled

    Trial Details

    Trial ID

    NCT00415402

    Start Date

    March 1 2007

    End Date

    July 1 2010

    Last Update

    August 22 2012

    Active Locations (1)

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    Institute of Home Economics, Delhi University

    New Delhi, India, 110016