Methods | The study was conducted in Matlab, a rural subdistrict in the east central plain of Bangladesh from November 2001 till December 2003. | |
Participants | Pregnant women with gestational age 6‐8 weeks, Hb greater than equal to 80 g/L and no serious disease were eligible for enrolment. | |
Interventions | MMN group (n = 1224) received vitamin A 800 mcg, D 200 IU, E 10 mg, C 70 mg, B1 1.4 mg, B2 1.4 mg, niacin 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 and iodine 150 mcg, while the other group received folic acid and iron (60 mg iron 400 mcg folic acid n = 1265 and 30 mg iron 400 mcg folic acid n = 1248). | |
Outcomes | Size at birth, gestational age at birth, perinatal mortality, maternal Hb at 30 weeks, birthweight, spontaneous abortions, infant mortality, motor development and behavioural development, infant micronutrient status, under 5 child mortality, blood pressure and kidney function in children, child growth outcomes, and adverse effects. 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. |
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Notes | Women were divided into 2 groups, that is, early food group and usual food group. Each food group was divided into 3 subgroups of MMN and iron folic acid groups. Iron folic acid given to all participants. There was no significant difference in baseline characteristics between randomisation groups. Maternal malnutrition was prevalent. Control group with 30 mg iron is included in this review. Data for child growth outcomes presented in a manner which precluded its inclusion in the analysis. Adverse effects included nausea (MMN supplementation 154/786, 30FeFA 126/763), vomiting (MMN 91/787, 30FeFA 54/762), loose motions (MMN 19/786, 30FeFA 18/763), heartburn (MMN 86/786, 30FeFA 83/763), and constipation (MMN 219/788, 30FeFA 227/762). Other trial (Gupta 2007) measuring this outcome presents data for all side‐effects using a composite measure. Analyses for individual side‐effects will be presented once additional trials are available. Cost data are published in Shaheen 2013. Stunting data relevant to this review are presented in Kahn 2013. The data for the Fe30F group are presented in Figure 1, a line graph, and we will contact the authors to clarify the exact numbers for inclusion in the next update. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "individual randomisation was done in blocks of 12" and "After enrolment, women were randomly assigned to 6 intervention groups". 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 | High risk | Attrition was (26%) 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 | Low risk | Comment: no other bias was identified. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "pills were identical in appearance, and monthly supplies were provided in identical bottles", " the mothers were unaware of their micronutrient supplement" and "double masking was practiced". Comment: study participants and caregivers were blinded to the treatment assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "pills were identical in appearance, and monthly supplies were provided in identical bottles", "the testers were unaware of children’s groups" and "double masking was practiced". Comment: outcome assessors were blinded to the treatment assignment. |