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 |
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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 |
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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 |
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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 |
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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 |
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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 |