Vitamin A Supplementation in Newborns Study - Full Text View

Sponsor:	Johns Hopkins Bloomberg School of Public Health
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

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 (retinol palmitate) oral, 48,000 IU	Phase III

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:

MedlinePlus related topics: Vitamin A

Drug Information available for: Retinol Vitamin A

U.S. FDA Resources

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

Estimated Enrollment:	14000
Study Start Date:	June 1998
Study Completion Date:	April 2001
Primary Completion Date:	April 2001 (Final data collection date for primary outcome measure)

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

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:

Rahmathullah L, Tielsch JM, Thulasiraj RD, Katz J, Coles C, Devi S, John R, Prakash K, Sadanand AV, Edwin N, Kamaraj C. Impact of supplementing newborn infants with vitamin A on early infant mortality: community based randomised trial in southern India. BMJ. 2003 Aug 2;327(7409):254.

Tielsch JM, Rahmathullah L, Thulasiraj RD, Katz J, Coles C, Sheeladevi S, John R, Prakash K. Newborn vitamin A dosing reduces the case fatality but not incidence of common childhood morbidities in South India. J Nutr. 2007 Nov;137(11):2470-4.

Tielsch JM, Rahmathullah L, Katz J, Thulasiraj RD, Coles C, Sheeladevi S, Prakash K. Maternal night blindness during pregnancy is associated with low birthweight, morbidity, and poor growth in South India. J Nutr. 2008 Apr;138(4):787-92.

Moulton LH, Rahmathullah L, Halsey NA, Thulasiraj RD, Katz J, Tielsch JM. Evaluation of non-specific effects of infant immunizations on early infant mortality in a southern Indian population. Trop Med Int Health. 2005 Oct;10(10):947-55.

Tielsch JM, Katz J, Thulasiraj RD, Coles CL, Sheeladevi S, Yanik EL, Rahmathullah L. Exposure to indoor biomass fuel and tobacco smoke and risk of adverse reproductive outcomes, mortality, respiratory morbidity and growth among newborn infants in south India. Int J Epidemiol. 2009 Oct;38(5):1351-63. Epub 2009 Sep 16.

Katz J, Tielsch JM, Thulasiraj RD, Coles C, Sheeladevi S, Yanik EL, Rahmathullah L. Risk factors for maternal night blindness in rural South India. Ophthalmic Epidemiol. 2009 May-Jun;16(3):193-7.

Coles CL, Rahmathullah L, Kanungo R, Thulasiraj RD, Katz J, Santosham M, Tielsch JM. Nasopharyngeal carriage of resistant pneumococci in young South Indian infants. Epidemiol Infect. 2002 Dec;129(3):491-7.

Coles CL, Rahmathullah L, Kanungo R, Thulasiraj RD, Katz J, Santhosham M, Tielsch JM. Vitamin A supplementation at birth delays pneumococcal colonization in South Indian infants. J Nutr. 2001 Feb;131(2):255-61.

Coles CL, Kanungo R, Rahmathullah L, Thulasiraj RD, Katz J, Santosham M, Tielsch JM. Pneumococcal nasopharyngeal colonization in young South Indian infants. Pediatr Infect Dis J. 2001 Mar;20(3):289-95.

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:	January 29, 2010
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:

Retinol palmitate
Vitamin A
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents

Physiological Effects of Drugs
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012