Friis 2004.
Methods | This trial was carried out in Zimbabwe. Dates of study: 1996‐1997 |
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Participants | Pregnant women who were between 22 and 36 weeks of gestation were eligible for enrolment. Participants (n =1669) were randomised into 2 groups, MMN group n = 837 and placebo n = 832. Out of the 1106 women that were followed, 725 were HIV‐ve and 360 were HIV+ve. | |
Interventions |
An IFA supplement was given separately as part of the routine antenatal care and was not part of the MMN tablet. Tablets were given from the day of enrolment until delivery. |
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Outcomes | Gestational age, birthweight, birth length, head circumference, preterm delivery (< 37 weeks of gestation), LBW (< 2500 g), IUGR‐LBW (> 37 weeks' gestational age and < 2500 g birthweight). It should be noted that the data for SGA were obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report. |
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Notes | Study intervention was approximately the RDA for pregnant or lactating women, except for vitamin A for which a higher amount was given.
Out of 1106 women who were followed, 725 were HIV‐ve whereas 360 were HIV+ve and HIV status of 21 was indeterminate. We have used data of HIV‐ve women only in this review. The intervention and the placebo groups were comparable at baseline except for the higher proportion of primigravida in the placebo group. Declarations of interest: the trial authors declared no conflict of interest. Funding sources: Council for Development Research, Danish International Development Assistance (to HF), the Danish Council for Medical Research (to HF), Southampton Insurance, Zimbabwe, the Foundation of 1870, BASF Health and Nutrition, the Hørslev Foundation, the Dagmar Marshall Foundation, the Sophus Jacobsens Foundation, and the Lily Benthine Lunds Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Allocation to daily supplementation with multimicronutrient or identical‐looking placebo tablets was based on simple blocked randomisation. The digits 0–5 in a computer‐generated random sequence were replaced by 6 preassigned permuted blocks of 4: AABB, ABAB, ABBA, BABA, BBAA, and BAAB; the digits 6–9 were deleted". Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "Containers with 110 multimicronutrient or placebo tablets, which were coded A or B, respectively, were delivered by the manufacturer together with the code in 2 sealed envelopes. Duplicate containers, which corresponded to the random sequence, were consecutively numbered from 1 to 1800. The study participants were numbered consecutively at recruitment". Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind", "multimicronutrient or identical‐looking placebo tablets" Comment: study participants and care providers were probably blinded to the treatment assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double blind", "multimicronutrient or identical‐looking placebo tablets" Comment: investigators were probably blinded to the treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition was > 20% and reasons for it were reported. Exclusions were not reported in the trial |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes in the methods section were presented in the paper. |
Other bias | Low risk | Comment: no other bias was identified. |