Baum 2017 (C).

Methods	Study design: cluster‐randomised, community‐based intervention trial Unit and method of allocation: 1 credit centre represented 1 cluster Method of sequence generation: computer‐generated list of random numbers Masking of participants, personnel, and outcome assessors: no blinding
Participants	Location of the study: 34 Fonkoze credit centres in rural Haiti Sample size: 521 Dropouts/withdrawals: 31 participants lost to follow‐up Age: children aged 6 to 59 months (29.7 months in intervention group, 27.6 months in control group) Sex: both sexes (58% male in intervention group, 47% male in control group) Socioeconomic status: not reported Baseline prevalence of anaemia: haemoglobin concentration of 9.7 g/dL in intervention group and 9.8 g/dL in control group Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: participation was limited to children aged 6 to 59 months who lived in a household whose head was a member of 1 of the credit centres. Children who were anaemic (having a blood haemoglobin concentration < 7 g/dL) or severely malnourished (having a mid‐upper arm circumference < 110 mm) at baseline were excluded
Interventions	34 clusters were randomly allocated to 1 of 2 groups Intervention (17 clusters, n = 262): MNP (vitamins A, B, B2, B6, B12, C, D, and E; folic acid; niacin; copper; iodine; iron; zinc; and selenium). Iron dose consisted of 2.5 mg ethylenediaminetetraacetic acid (EDTA) plus 2.5 mg ferrous lactate Comparison (17 clusters, n = 259): no intervention. Control group received MNP after 3‐month follow‐up at the conclusion of the study Duration of intervention: 3 months
Outcomes	Primary: haemoglobin concentration Secondary: percentage of children with anaemia (those with haemoglobin < 11 g/dL) Timing of outcome assessment: baseline and during follow‐up 3 months later
Notes	Study start date: February 2012 Study end date: March 2012 Conflict(s) of interest: not reported Funding source(s): Vitamin Angels. The first study author was supported by a sub‐award from the US Agency for International Development, for which Fonkoze is the prime awardee. Two study authors were employed by Fonkoze Malaria‐endemic area: yes Comments Imperfect compliance due to dilution (i.e. MNPs were added to 1 meal per day in the home, and the product may have been shared with other household members) Exact MNP composition is unclear
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: computer‐generated list of random numbers was used
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding Quote: "... participants and field staff members were not blinded to their credit centers’ group assignment..."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no blinding Quote: "... participants and field staff members were not blinded to their credit centers’ group assignment..."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 31 participants lost to follow‐up; no evidence of a difference in attrition between intervention (246/262; 6.1%) and control (236/259; 8.9%) groups
Selective reporting (reporting bias)	Low risk	Comment: appears to be no selective reporting, as outcomes pre‐specified in the trial registration were reported in the final publication
Other bias	High risk	Comment: intervention and control groups differed in several variables at baseline