Overview

Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates

Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
BASF
Bill and Melinda Gates Foundation
Harare City Health Department, Harare, Zimbabwe
McGill University Health Center
McGill University Health Centre/Research Institute of the McGill University Health Centre
Rockefeller Foundation
SARA and Linkages Projects, Academy for Educational Development, Washington DC.
United States Agency for International Development (USAID)
Université de Montréal
University of Zimbabwe
Treatments:
Retinol palmitate
Vitamin A
Vitamins
Criteria
Inclusion Criteria:

- mothers and their neonates delivering at a study recruitment site during the
recruitment period

Exclusion Criteria:

- mother in intensive care unit

- mother not fully conscious

- maternal temperature > 39˚

- Mother is 'nil per mouth' (NPO)

- Mother is terminally ill as indicated in medical notes

- Infant is NPO

- Infant is terminally ill as indicated in medical notes

- Infant birth weight <1500 g

- Infant is a twin or triplet delivery

- Regular place of residence is outside Harare.