Choudhury 2012.
Methods | Cluster‐randomised non‐inferiority trial. 2‐arm study. | |
Participants | 478 pregnant women (gestational age 14–22 weeks) attending 42 antenatal care centres (ANC) in the rural sub district of Kaliganj in central Bangladesh. Women with haemoglobin lower than 70 g/L or greater than 140 g/L, with more than 22 weeks of gestation, or who were already taking iron supplements prior to the start of the study were excluded. | |
Interventions | Participants were randomised, at the cluster level (ANC), to 1 of 2 interventions: group 1 (21 clusters, n = 243) received micronutrient powders containing (60 mg of elemental iron as ferrous fumarate), 400 μg of folic acid, 30 mg of vitamin C, and 5 mg of zinc) daily or group 2 (21 clusters, n = 235) received tablets containing 60 mg elemental iron and 400 μg (0.4 mg) folic acid daily. Participants from group 1 were instructed to sprinkle the full content of a package of the powders into any semi‐solid or semi‐liquid food. | |
Outcomes | Haemoglobin concentrations, mild and moderate anaemia at baseline, 24, 28 and 32 weeks of gestation, adherence to intervention. | |
Notes | Baseline nutritional status of women at the start of intervention mixed group 1: 50% (n = 121) and group 2: (39.1%, n = 92). Malaria status in the study area: absent/unknown/unreported malaria at the time of the trial. Dosage of elemental iron in the micronutrient powder (per portion added or individual sachet): more than 30 mg. Provision scheme of the micronutrient powder intervention: daily. Source of funding: HJ Heinz Company Foundation. Clustering effect accounted in the original analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not reported. |
Allocation concealment (selection bias) | Low risk | As this is a cluster‐randomised trial, the risk of selection bias at the individual level is low. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded to the interventions. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall attrition of 15%, similar in both groups. |
Selective reporting (reporting bias) | Unclear risk | It is unclear if outcomes other than those reported were assessed and purposely not reported. |
Other bias | High risk | Higher prevalence of baseline anaemia among participants from group 1 receiving micronutrient powders (50.0%) compared to the participants in group 2 receiving iron and folic acid tablets (39.1%). |