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.