Randomised trial of effects of vitamin supplements on pregnancy outcomes
and T cell counts in HIV-1-infected women in Tanzania.
Fawzi WW; Msamanga GI; Spiegelman D; Urassa EJ; McGrath N; Mwakagile
D; Antelman G; Mbise R; Herrera G; Kapiga S; Willett W; Hunter DJ
Lancet 1998 May 16;351(9114):1477-82
BACKGROUND: In HIV-1-infected women,
poor micronutrient status has been associated with faster progression
of HIV-1 disease and adverse birth outcomes. We assessed the effects of
vitamin A and multivitamins on birth outcomes in such women. METHODS:
In Tanzania, 1075 HIV-1-infected pregnant women at between 12 and 27 weeks'
gestation received placebo (n=267), vitamin A (n=269), multivitamins excluding
vitamin A (n=269), or multivitamins including vitamin A (n=270) in a randomised,
double-blind, placebo-controlled trial with a 2x2 factorial design. We
measured the effects of multivitamins and vitamin A on birth outcomes
and counts of T lymphocyte subsets. We did analyses by intention to treat.
RESULTS: 30 fetal deaths occurred among women assigned multivitamins compared
with 49 among those not on multivitamins (relative risk 0.61 [95% CI 0.39-0.94]
p=0.02). Multivitamin supplementation decreased the risk of low birthweight
(<2500 g) by 44% (0.56 [0.38-0.82] p=0.003), severe preterm birth (<34
weeks of gestation) by 39% (0.61 [0.38-0.96] p=0.03), and small size for
gestational age at birth by 43% (0.57 [0.39-0.82] p=0.002). Vitamin A
supplementation had no significant effect on these variables. Multivitamins,
but not vitamin A, resulted in a significant increase in CD4, CD8, and
CD3 counts. INTERPRETATION: Multivitamin supplementation is a
low-cost way of substantially decreasing adverse pregnancy outcomes and
increasing T-cell counts in HIV-1-infected women. The clinical relevance
of our findings for vertical transmission and clinical progression of
HIV-1 disease is yet to be ascertained.