Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania.
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.


CONCLUSIONS
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.
Fawzi
W W
WW
Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts 02115, USA.
Msamanga
G I
GI
Spiegelman
D
D
Urassa
E J
EJ
McGrath
N
N
Mwakagile
D
D
Antelman
G
G
Mbise
R
R
Herrera
G
G
Kapiga
S
S
Willett
W
W
Hunter
D J
DJ
D017252:CD3 Complex; D018791:CD4 Lymphocyte Count; D018414:CD8-Positive T-Lymphocytes; D003906:Developing Countries; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D015497:HIV-1; D006801:Humans; D007231:Infant, Newborn; D018655:Lymphocyte Count; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D011256:Pregnancy Outcome; D013636:Tanzania / Q000453:epidemiology; D014801:Vitamin A / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*
D017252:CD3 Complex; D014815:Vitamins; D014801:Vitamin A