Somassè 2018 (C).

Methods	Study design: cluster‐randomised controlled community trial Unit and method of allocation: randomisation at the village level from 2 different municipalities Method of sequence generation: computer‐aided selection of 10 villages to intervention and 10 villages to control in each of 2 municipalities Masking of participants, personnel, and outcome assessors: not possible to blind allocation to treatment group; study staff also not blinded
Participants	Location of the study: Circle of the Nioro, municipalities of Korera‐Kore and Sandare, Mali Sample size: 702 children (351 per arm) Age: 6 to 23 months Sex: 49% male in intervention group, 44% male in control group Socioeconomic status: approximately 80% of mothers with no school attendance; no differences between groups Baseline prevalence of anaemia: 89.9% Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: all children aged 6 to 23 months were eligible for inclusion. Those with severe acute malnutrition and those receiving iron supplementation at the time of the study were excluded
Interventions	Villages were randomised to 2 groups Intervention (396 participants/20 clusters): micronutrient powder to be taken daily for 90 days (containing 400 μg of vitamin A, 150 μg of folic acid, 5 μg of vitamin D3, 90 μg of iodine, 17 μg of selenium, 0.9 μg of vitamin B12, 6 mg of niacin, 10 mg of Fe, 4.1 mg of zinc, 0.56 mg of copper, 0.5 mg of thiamin, 0.5 mg of riboflavin, 30 mg of vitamin C, 0.5 mg of vitamin B6, and 5 mg of vitamin E). Mothers also received counselling on optimal infant and young child feeding Comparison (326 participants/20 clusters): group counselling without supplementation Duration of intervention: 3 months
Outcomes	Primary: weight, haemoglobin, anaemia Secondary: length, change in mid‐upper arm circumference (MUAC), reported illness (diarrhoea or fever) Timing of outcome assessment: primary outcomes, as well as length and MUAC, assessed at baseline and 3 months; illness assessed each month over 3 months of follow‐up
Notes	Study start date: not reported Study end date: not reported Conflict(s) of interest: none reported Funding source(s): Red Cross of Belgium Malaria‐endemic area: yes Comment Analysis performed intent‐to‐treat using regression techniques, with standard errors taking account of the cluster design
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: computer‐generated assignment
Allocation concealment (selection bias)	Unclear risk	Comment: not possible to blind allocation to treatment group
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: field staff and investigators not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: not blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 24.9% loss to follow‐up
Selective reporting (reporting bias)	Low risk	Comment: appears to be no selective reporting, as outcomes pre‐specified were reported in the final publication
Other bias	Low risk	Comment: appears to be free of other sources of bias