NCT00128557

Brief Summary

The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,937

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 3, 2022

Status Verified

April 1, 2007

Enrollment Period

2.9 years

First QC Date

August 9, 2005

Last Update Submit

September 28, 2022

Conditions

Mortality Through Six Months of AgeVitamin A Deficiency

Keywords

Vitamin ANewborn healthInfant MortalitySupplementationMicronutrientsBangladesh

Outcome Measures

Primary Outcomes (1)

  • 24-week infant mortality rate

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Supplement containing soybean oil with a small amount of vitamin E as an antioxidant

Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)

Vitamin A

ACTIVE COMPARATOR

15,000 ug retinol equivalents (50,000 International Units)

Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)

Interventions

vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)DIETARY_SUPPLEMENT

Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo

PlaceboVitamin A

Eligibility Criteria

Age1 Minute - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JiVitA Bangladesh Project

Rangpur, Rajshahi Division, Bangladesh

Location

Related Publications (2)

  • Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.

    PMID: 28490513DERIVED

  • Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.

    PMID: 21832026DERIVED

Related Links

MeSH Terms

Conditions

Vitamin A DeficiencyInfant Death

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rolf DW Klemm, Dr PH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Keith P West, Jr., Dr. P.H.

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Parul Christian, Dr. P.H.

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Mahbubar Rashid, MBBS, MSc, MBA

    JiVitA Bangladesh Project

    STUDY DIRECTOR

  • Alain B. Labrique, MSc

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Alfred Sommer, M.D.

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 10, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 3, 2022

Record last verified: 2007-04

Locations

BA(1)