Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates

Summary

The ZVITAMBO PROJECT is testing whether giving mothers and infants a single large dose of vitamin A during the immediate post partum period will reduce:

1. Infant Mortality Can oral administration of a single 50,000 IU dose of vitamin A to newborn infants, a single 400,000 IU dose of vitamin A given to their lactating mothers, or supplementation of both the mother and infant during the immediate post partum period reduce infant mortality by at least 30%?
2. Mother to Child HIV transmission during breast feeding Can oral administration of a single large dose of vitamin A given during the immediate post partum period to HIV seropositive lactating women and/or their babies reduce HIV transmission via breast feeding by at least 30%?
3. Sexually transmitted HIV infection of post partum women Can a single 400,000 IU dose of vitamin A given during the immediate post partum period to HIV seronegative women reduce their likelihood of becoming HIV infected during the post partum year by at least 25%?
4. Infant feeding in the context of HIV: An operational research study was initiated mid-way through the trial to determine how UNAIDS Guidelines on infant feeding in the context of HIV could be effectively implemented and to measure the impact of such a program on infant feeding practices and postnatal HIV transmission.

Substudies:

Random subsamples of maternal and infant blood were evaluated for anemia and iron status to determine the effect of vitamin A on hematopoiesis and serum and breast milk retinol (mothers) and modified relative dose response test (infants) to determine the effect of vitamin A on vitamin A status.

A subsample of maternal and infant blood samples were evaluated for the presence of HLA-E, HLA-G, and TAP polymorphisms and their relation to prevalent HIV infection in mothers and risk of mother to child transmission.

Conditions

• Vitamin A Deficiency
• HIV

Interventions

DRUG

Vitamin A (retinyl palmitate)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• University of Zimbabwe

  collaborator OTHER

• Harare City Health Department, Harare, Zimbabwe

  collaborator UNKNOWN

• United States Agency for International Development (USAID)

  collaborator FED

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Rockefeller Foundation

  collaborator OTHER

• BASF

  collaborator INDUSTRY

• SARA and Linkages Projects, Academy for Educational Development, Washington DC.

  collaborator UNKNOWN

• Université de Montréal

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Jean H Humphrey, ScD · Johns Hopkins Bloomberg School of Pubic Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1997-11-30

Primary Completion

2001-05-31

Completion

2020-12-31