Zagre 2007

Methods	This study was a cluster‐randomised, double‐blind controlled programmatic study in rural Niger aiming to compare MMN supplementation versus iron and folic acid.
Participants	Women residing in target villages and experiencing amenorrhoea for less than 12 weeks were eligible for recruitment. All villages within the coverage of the 17 health centres of Mayahi district were included. Women with night blindness and/or signs of severe anaemia were excluded.
Interventions	Micronutrient group (n = 1893) received vitamin A 800 mcg, D 200 IU, E 10 mg, C 70 mg, B1 1.4 mg, B2 1.4 mg, B3 18 mg, B6 1.9 mg, B12 2.6 mg, folic acid 400 mcg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 mcg, iodine 150 mcg. Control (n = 1777) received iron and folic acid.
Outcomes	Birthweight and incidence of LBW, miscarriage, stillbirth, maternal mortality. It should be noted that the data for SGA was obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report.
Notes	Study participants received reproductive health services including malaria chemoprophylaxis, behavior change communication activities to increase awareness and adoption of better lifestyles (feeding and rest during pregnancy). Outreach prenatal care sessions were also conducted throughout intervention villages. Randomisation resulted in comparable groups for most baseline characteristics except for households and more preventive measures against malaria (more in MMN group) and less education and more poverty in iron/folic acid group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Villages ‐ not individuals were randomly assigned to one treatment group or the other". Comment: method used for generating the randomisation sequence was not described in sufficient detail to permit judgement.
Allocation concealment (selection bias)	Unclear risk	Comment: method used for allocation concealment was not described to permit judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition was 18%. Reasons for attrition were reported. Exclusion data were not reported.
Selective reporting (reporting bias)	Low risk	Comment: all outcomes mentioned in the methods section were presented in the paper.
Other bias	Low risk	Comment: no other bias was identified.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Because the two supplements did not look identical and may have been recognizable, a coding system was put in place by the SONIPHAR pharmaceutical company in Niger. six codes were assigned to the treatments: three for iron/folic acid and three for multimicronutrient supplements. SONIPHAR packaged the supplements in boxes with identical labelling except for the supplement code. Health workers, traditional midwives, and data collectors were informed that each supplement came in two sizes and colors, so that the code letter did not distinguish which supplement was used". Comment: participants and caregivers were probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Because the two supplements did not look identical and may have been recognizable, a coding system was put in place by the SONIPHAR pharmaceutical company in Niger. six codes were assigned to the treatments: three for iron/folic acid and three for multimicronutrient supplements. SONIPHAR packaged the supplements in boxes with identical labelling except for the supplement code. Health workers, traditional midwives, and data collectors were informed that each supplement came in two sizes and colors, so that the code letter did not distinguish which supplement was used". Comment: outcome assessors were probably blinded to the treatment assignment.