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. 2017 Apr 13;2017(4):CD004905. doi: 10.1002/14651858.CD004905.pub5
Methods A double‐blind cluster‐randomised trial conducted at Lombok island of Indonesia between July 1, 2001 and April 1, 2004.
Participants Pregnant women of any gestational age assessed by physical exam and reported LMP.
Interventions MMN group (n = 15804)) received iron 30 mg, folic acid 400 mcg, vitamin A 800 mcg, D 200 IU, E 10 mg, C 70 mg, B1 1.4 mg, B6 1.9 mg, B12 2.6 mcg, zinc 15 mg, copper 2 mg, selenium 65 mcg, iodine 150 mcg and niacin 18 mg. Placebo group (n = 15,486) received iron 30 mg and folic acid 400 mcg.
Outcomes Early infant mortality (death within 12 weeks of birth), neonatal mortality (death within 28 days of birth), early neonatal mortality (death within 7 days of birth), late neonatal mortality (death between 7 and 28 days of birth), postneonatal mortality (death between 28 days and 12 weeks of birth), fetal loss, abortions (fetal loss before 28 weeks of gestation), still births (death between 28 weeks and before delivery), perinatal mortality (still birth or death within 7 days of birth), maternal mortality related to pregnancy up to 12 weeks postpartum, maternal cognition and mood, and child cognition (motor, cognitive and socioeconomic abilities) at 42 months of age.
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 Women in both groups received supplements throughout pregnancy until 90 days postpartum. Intervention and placebo groups were comparable in terms of baseline characteristics.
Study was stopped early due to insufficient funds.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Before enrolment, midwife identification numbers were sequentially allocated to computer‐generated, randomly permuted blocks of groups numbered one to eight, stratified by community health centre or village health clinic".
Comment: probably done.
Allocation concealment (selection bias) Low risk Quote: "midwives at village health centres and community health centres were assigned midwife identification numbers" and "Before enrolment, midwife identification numbers were sequentially allocated to computer‐generated, randomly permuted blocks of groups numbered one to eight, stratified by community health centre or village health clinic".
Comment: probably done.
Incomplete outcome data (attrition bias) All outcomes Low risk Exclusion (25.2%) and attrition (5%) were reported along with their reasons.
Selective reporting (reporting bias) Low risk Comment: all outcomes mentioned in the methods section were presented in the paper.
Other bias Unclear risk Study was stopped early due to insufficient funds.
Blinding of participants and personnel (performance bias) All outcomes Low risk Quote: "All study scientists and personnel, government staff and enrolees were unaware of the allocation." and "The code to indicate which strip was IFA or MMN was known only by the manufacturing production manager and a quality control officer from UNICEF, Copenhagen, neither of whom had any connection to the study or its personnel". Comment: participants and caregivers were probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "All study scientists and personnel, government staff and enrolees were unaware of the allocation." and "The code to indicate which strip was IFA or MMN was known only by the manufacturing production manager and a quality control officer from UNICEF, Copenhagen, neither of whom had any connection to the study or its personnel". Comment: outcome assessors were probably blinded to the treatment assignment.