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. 2009 Jan 21;2009(1):CD006734. doi: 10.1002/14651858.CD006734.pub2

Fawzi 2002.

Methods Randomized controlled trial
Participants Pregnant women presenting to public antenatal clinics (in the era before interventions to prevent MTCT of HIV were available locally) between 12 and 27 weeks gestation who resided in Dar es Salaam, Tanzania, and who intended to stay in the city until after delivery and for at least 1 year thereafter were enrolled. Median age ˜24 years;  CD4 count ˜ 420
Interventions Eligible women were randomly assigned in a two‐by‐two factorial design to receive a daily oral dose of one or four regimens from enrolment and throughout the pregnancy and lactation periods:

  1. vitamin A alone (30 mg beta‐carotene plus 5000 IU preformed vitamin A)

  2. multivitamins excluding vitamin A (20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 micrograms B12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid)

  3. multivitamins including vitamin A in the same doses as above

  4. placebo


At delivery, women in groups 1 and 3 received an additional oral dose of vitamin A (200,000 IU), and women in groups 2 and 4 received placebo.
Those infants whose mothers received multivitamins were compared to infants whose mothers did NOT receive multivitamins.  Similarly, those infants whose mothers received vitamin A were compared to infants whose mothers did NOT receive vitamin A.
Outcomes HIV infection status:
Multivitamins (vitamins B, C, and E) had no effect on the overall risk of HIV transmission (RR = 1.04; 95%CI: 0.82‐1.32; p = 0.76).  Multivitamins were associated with non‐statistically significant reductions in transmission through breastfeeding. 
More cases of HIV infection were observed among children of mothers in the vitamin A arm compared with those who did not receive vitamin A  (RR=1.38; 95%CI: 1.09‐1.76; p = 0.009). 
Mortality:
Multivitamins (vitamins B, C, and E) had a modest and not statistically significant reduction in mortality by 24 months or the combined risks of infection and mortality among children. 
Notes Not all study details were provided in this publication.  "Details of the study design have been published [9,10]" (referring to Fawzi 2000 and Fawzi 1998). Fawzi 2000 says: "Details of the study design have been published elsewhere (10,11)" (referring to Fawzi 1999 and Fawzi 1998).
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk "We assigned women randomly to receive a daily oral dose." (From Fawzi 1999)
Allocation concealment? High risk Not addressed
Blinding? 
 All outcomes Low risk "We realized that unblinding, whether real or based on an impression or perception that may develop among subjects or staff, is more likely to occur if regimens are color‐coded or bear simple numeric codes. To minimize this risk, we provided the regimen in bottles labeled with the subjects’ names and identification numbers, and made active tablets and placebo indistinguishable, so that neither the subjects nor the investigators could identify which subjects were randomized to the same regimen." (From Fawzi 1999)
Incomplete outcome data addressed? 
 All outcomes Low risk "We also developed a system for tracking the survival of all women not in active follow‐up, by visiting their homes regularly and asking questions of neighbors, relatives, and friends. Through these methods, we have kept loss to follow‐up down to about 5% per year. We anticipated these inevitable losses, and other losses due to mortality, and factored them in our sample‐size calculation." (From Fawzi 1999)
Free of selective reporting? Low risk No problems apparent.
Free of other bias? Low risk No problems apparent.