Christofides 2006 (C).
Methods |
Study design: 5‐arm, cluster‐randomised clinical trial Unit and method of allocation: at housing compound level Method of sequence generation: random digit generator used Masking of participants, personnel, and outcome assessors: participants blinded to multiple micronutrient composition groups; care providers and field staff blinded to form and dose of iron in the multiple MNPs; blinding of outcome assessors unclear |
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Participants |
Location of the study: Ghana Sample size: 133 Dropouts/withdrawals: 118 (89%) children completed the study Age: 6 to 18 months Sex: both sexes Socioeconomic status: not reported Baseline prevalence of anaemia: anaemic (100%) Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: 60% to 73.7% Inclusion and exclusion criteria: infants with body temperature ≤ 37.5 °C, no history of iron supplementation within 2 weeks before recruitment, and ingesting semi‐solid or solid weaning foods were eligible for inclusion. Infants with severe anaemia (haemoglobin < 70 g/L) were excluded |
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Interventions | 127 clusters of housing compounds (n = 133 children) were randomised to 5 groups Interventions*
Comparison Group 5* (n = 25, clusters 24): children received iron drops containing 15 mg of elemental iron per mL (as ferrous glycine sulphate drops) daily, between meals *For the purposes of this review, we have considered the 4 MNPs together and compared with group 5 Duration of intervention: 2 months |
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Outcomes |
Primary: haemoglobin Secondary: serum ferritin, serum transferrin receptors, iron deficiency anaemia, adherence, ease of use, diarrhoeal episodes per child, darkening of stools, staining of teeth Timing of outcome assessment: 3 and 8 weeks post intervention |
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Notes |
Study start date: April 2003 Study end date: September 2003 Conflict(s) of interest: S Zlotkin (last author) owns the intellectual property rights to micronutrient Sprinkles™. All profit net of expenses from the licensing of Sprinkles is donated to the Hospital for Sick Children Foundation. No other conflicts of interests Funding source(s): funded, in part, by grants from Canadian Institutes of Health Research and the HJ Heinz Company Foundation Malaria‐endemic area: yes Comments None |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: cluster randomisation by housing compounds, using random digit generator |
Allocation concealment (selection bias) | Low risk | Comment: not described; however, because the intervention was allocated at cluster (housing compounds) level, selection bias at the individual level is unlikely |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: participant blinded to the multiple micronutrient composition groups; care provider and field staff blinded to the form and dose of iron in the multiple MNP |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: blinding of outcome assessment unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 7 out of 108 participants in the MNP groups (groups 1 to 4) lost to follow‐up and 4 out of 25 in the iron drop groups lost to follow‐up; no imbalance among groups |
Selective reporting (reporting bias) | Unclear risk | Comment: information insufficient to permit judgement |
Other bias | Low risk | Comment: appears to be free of other sources of bias |