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. 2020 Feb 28;2020(2):CD008959. doi: 10.1002/14651858.CD008959.pub3

Lanou 2019 (C).

Methods Design: cluster‐randomised trial
Unit and method of allocation: villages within 4 municipalities
Method of sequence generation: a total of 74 clusters (villages) were eligible; 12 were excluded, resulting in 62 clusters. Villages were randomly allocated to intervention (n = 31) and control (n = 31) groups
Masking of participants, personnel, and outcome assessors: allocation of villages to study groups using letter blindly selected from a text, "i", and selecting village names with first letter closest to "i" in the intervention group. Blinding of participants and personnel not described. Blinding of outcome assessors not clearly described
Participants Location of the study: rural area of the health district of Tougan, in Northwest Burkina Faso
Sample size: 4629 representing 2233 children at baseline (control = 1132, intervention = 1101) and 2396 at end‐line survey (control = 1156, intervention = 1240)
Age: children aged 6 to 23 months
Sex: 50.8% female in intervention group, 49.7% female in control group
Socioeconomic status: low socioeconomic status
Baseline prevalence of anaemia: 81.2% in control group, 75.3 in intervention group
Baseline prevalence of soil helminths: not reported
Baseline malaria prevalence: holoendemic, but baseline prevalence not reported
Inclusion and exclusion criteria: all children aged 6 to 23 months living in study villages before and after intervention. No exclusion criteria reported
Interventions 62 clusters were randomly allocated
Intervention (31 clusters): intervention package consisted of (a) monthly supply of MNP to be taken on alternate days (15 micronutrients = 10 mg of elemental iron, 4.1 mg of zinc, 400 μg of vitamin A, 30 mg of vitamin C, 5 μg of vitamin D, 5 mg of vitamin E, 0.5 mg of B1, 0.5 mg of B2, 6 mg of B3, 0.5 mg of B6, 0.9 μg of B12, 150 μg of folic acid, 0.56 mg of copper, 17 μg of selenium, 90 μg of iodine); (b) child growth monitoring; (c) child‐centred counseling; and (d) cooking demonstrations
Comparison (31 clusters): child growth monitoring only
Duration of intervention: 12 months
Outcomes Primary: stunting, minimum dietary diversity
Secondary: anthropometry (weight, height, mid‐upper arm circumference), haemoglobin, malaria (fever and rapid diagnostic kit), morbidity (fever, diarrhoea, lower respiratory tract infection)
Timing of outcome assessment: 12 months
Notes Study start date: November 2014
Study end date: October 2015
Conflict(s) of interest: none reported
Funding source(s): micronutrient initiative
Malaria‐endemic area: yes
Comment
Study not powered to detect effects on anaemia. Analysis repeated cross‐sectional surveys, rather than comparing longitudinal changes in the same individuals in each study group. Suboptimal coverage and duration of intervention in some villages. Cluster‐level analyses were carried out. Sample sizes for growth data not reported, so results not included
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: all eligible villages were listed, and villages within a municipality were paired according to population size and distance from the nearest health centre
Allocation concealment (selection bias) Low risk Comment: allocation of villages to study groups using letter blindly selected from a text, "i", and selecting village names with first letter closest to "i" in the intervention group
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: not attempted; both researchers and caretakers were aware of the intervention, and no placebo was used
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: not attempted; both researchers and caretakers were aware of the intervention, and no placebo was used
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: repeated cross‐sectional surveys with similar sample size in baseline and end‐line surveys.
Selective reporting (reporting bias) Unclear risk Comment: information insufficient to permit judgement
Other bias High risk Comment: suboptimal coverage and duration of intervention in some villages. Coverage or intake of MNP not reported