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Vitamin A Supplementation in Newborns Study

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ClinicalTrials.gov Identifier: NCT00114868
Recruitment Status : Completed
First Posted : June 20, 2005
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Infant, Newborn Drug: Vitamin A Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14035 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin A Supplementation in Newborns Study
Study Start Date : June 1998
Primary Completion Date : April 2001
Study Completion Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Drug: Vitamin A
Other Name: vitamin A (retinol palmitate) oral, 48,000 IU


Outcome Measures

Primary Outcome Measures :
  1. mortality in first 6 months of life

Secondary Outcome Measures :
  1. incidence of diarrhea, dysentery or respiratory infection
  2. growth

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 20, 2005    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: January 2010

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

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