Vitamin A Supplementation in Newborns Study

This study has been completed.
Sponsor:
Collaborator:
Aravind Centre for Women and Children, Madurai, Tamil Nadu, India
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00114868
First received: June 17, 2005
Last updated: April 24, 2013
Last verified: January 2010
  Purpose

This study was a randomized, community-based trial testing whether dosing newborn infants in the first few days after delivery with a large dose of vitamin A could reduce early infant morbidity, mortality and improve growth. Pregnant women in 2 districts of Tamil Nadu State in southern India were identified and recruited for participation. When the child was born, study staff were notified and traveled to the house to collect information and provide the vitamin A or placebo dose. Children were visited every two weeks until they were 6 months of age to collect information about vital status and morbidity. All children were discharged from the study at 6 months after growth was assessed and they received a 100,000 IU dose of vitamin A.


Condition Intervention Phase
Infant, Newborn
Drug: Vitamin A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin A Supplementation in Newborns Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • mortality in first 6 months of life

Secondary Outcome Measures:
  • incidence of diarrhea, dysentery or respiratory infection
  • growth

Enrollment: 14035
Study Start Date: June 1998
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin A
48,000 IU vitamin A oral dose spread over 2 days as soon as possible after birth.
Drug: Vitamin A
Other Name: vitamin A (retinol palmitate) oral, 48,000 IU
Placebo Comparator: Placebo
placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All live born children

Exclusion Criteria:

  • Children who die prior to study staff visiting the home to enroll the child and deliver the assigned intervention.
  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: NCT00114868

Locations
India
Aravind Center for Women and Children
Madurai, Tamil Nadu, India
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Aravind Centre for Women and Children, Madurai, Tamil Nadu, India
Investigators
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Lakshmi Rahmathullah, MBBS Aravind Center for Women and Children
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00114868     History of Changes
Other Study ID Numbers: H.22.02.03.06.C1
Study First Received: June 17, 2005
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
vitamin A
mortality
newborn
liveborn infants

Additional relevant MeSH terms:
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014