NCT00114868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,035

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 1998

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2005

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2010

Enrollment Period

2.8 years

First QC Date

June 17, 2005

Last Update Submit

March 1, 2017

Conditions

Infant, Newborn

Keywords

vitamin Amortalitynewbornliveborn infants

Outcome Measures

Primary Outcomes (1)

  • mortality in first 6 months of life

Secondary Outcomes (2)

  • incidence of diarrhea, dysentery or respiratory infection

  • growth

Study Arms (2)

Vitamin A

ACTIVE COMPARATOR

48,000 IU vitamin A oral dose spread over 2 days as soon as possible after birth.

Drug: Vitamin A

Placebo

PLACEBO COMPARATOR

placebo

Drug: Vitamin A

Interventions

Vitamin ADRUG
Also known as: vitamin A (retinol palmitate) oral, 48,000 IU
PlaceboVitamin A

Eligibility Criteria

Age1 Minute - 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All live born children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Center for Women and Children

Madurai, Tamil Nadu, India

Location

Related Publications (11)

  • 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. doi: 10.1136/bmj.327.7409.254.

    PMID: 12896935RESULT

  • 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. doi: 10.1093/jn/137.11.2470.

    PMID: 17951487RESULT

  • 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. doi: 10.1093/jn/138.4.787.

    PMID: 18356336RESULT

  • 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. doi: 10.1111/j.1365-3156.2005.01434.x.

    PMID: 16185228RESULT

  • 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. doi: 10.1093/ije/dyp286. Epub 2009 Sep 16.

    PMID: 19759098RESULT

  • 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. doi: 10.1080/09286580902863080.

    PMID: 19437315RESULT

  • 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. doi: 10.1017/s0950268802007586.

    PMID: 12558331RESULT

  • 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. doi: 10.1093/jn/131.2.255.

    PMID: 11160543RESULT

  • 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. doi: 10.1097/00006454-200103000-00014.

    PMID: 11303832RESULT

  • Coles CL, Rahmathullah L, Kanungo R, Katz J, Sandiford D, Devi S, Thulasiraj RD, Tielsch JM. Pneumococcal carriage at age 2 months is associated with growth deficits at age 6 months among infants in South India. J Nutr. 2012 Jun;142(6):1088-94. doi: 10.3945/jn.111.156844. Epub 2012 Apr 25.

    PMID: 22535764RESULT

  • Garcia CR, Mullany LC, Rahmathullah L, Katz J, Thulasiraj RD, Sheeladevi S, Coles C, Tielsch JM. Breast-feeding initiation time and neonatal mortality risk among newborns in South India. J Perinatol. 2011 Jun;31(6):397-403. doi: 10.1038/jp.2010.138. Epub 2010 Dec 16.

    PMID: 21164424RESULT

MeSH Terms

Interventions

Vitamin Aretinol palmitate

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • James M Tielsch, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Lakshmi Rahmathullah, MBBS

    Aravind Center for Women and Children

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2005

First Posted

June 20, 2005

Study Start

June 1, 1998

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

March 3, 2017

Record last verified: 2010-01

Locations

IN(1)