Engstrom 2008 (C).
Methods | Cluster‐randomised trial. 3 arm design in which health facilities were the unit of randomisation. | |
Participants | 391 children, both sexes (184 females (47%)), 6 months old. Study carried out through primary healthcare units in Rio de Janeiro, Brazil. 15 health care centres (6 intervention, 9 control). Inclusion criteria: absence of iron supplementation in the month preceding recruitment and negative for sickle cell anaemia. Baseline prevalence of anaemia (taken from the control group): 60.4%. Socioeconomic status:approximately 30% of the mothers worked outside the home; most families (> 90%) had access to radio and television, but < 20% had access to a car. |
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Interventions | Health facilities were allocated to one of the following groups: Group 1 (n = 188): children received weekly supplementation with 25 mg of elemental iron (as oral ferrous sulphate) per week in syrup and education on anaemia and diet; Group 2 (n = 188): children received daily supplements containing 12.5 mg elemental iron dailyand education on anaemia and diet; Group 3 (n = 94): children received received no intervention and was recruited retrospectively. Length of the intervention: 24 weeks. For the purposes of this review we only compared groups 1 and 2. |
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Outcomes | Haemoglobin, anaemia (Hb <110 g/L) and adherence. | |
Notes | Analyses were performed taking into account cluster sampling. Non‐malaria area. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Healthcare units were randomly selected. Method of sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Not reported. Since the intervention was allocated at health care unit level, it is unlikely there was a selection bias at the individual level. |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants: Mothers were aware of supplements Personnel: Clinic staff were aware of supplements Outcome assessors: Unlikely Control group identified retrospectively so they were not aware of trial during treatment phase. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 38/188 (20.2%) were lost to follow up the daily group and 41/188 (21.8%) in the weekly group. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | Baseline characteristics were similar for most variables. Regression analysis was carried out to identify possible confounders and where possible confounders accounted for at least 10% of variation they were entered into the final model. However for anaemia no confounders were maintained in the final regression analysis. |