Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
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.