Schultink 1995.
Methods | Randomised clinical trial. 2‐arm design with individual randomisation. | |
Participants | 87 children, both sexes, aged 2‐5 years, from Subdistrict Kelurahan Tenga of East Jakarta, Indonesia. The initial selection criterion was a haemoglobin concentration < 110 g/L. 96 children were invited to receive anthelmintic treatment before starting iron supplementation; only 87 accepted and were randomised. | |
Interventions | Participants were allocated to one of the following groups: Group 1 (n = 44): children were supplemented daily with 30 mg elemental iron (as ferrous sulphate dissolved in 5 mL syrup); Group 2 (n = 43): children were supplemented twice a week with 30 mg elemental iron (as ferrous sulphate dissolved in 5 mL syrup) (total 60 mg of iron per week). Length of the intervention: 8 weeks. |
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Outcomes | Haemoglobin, ferritin, zinc protoporphyrin, mean changes of haematological variables (anaemia prevalence taken from Beaton 1999). | |
Notes | Parents and supervising health staff were instructed that each child should take 5 mL from the small bottle on Mondays and Fridays and 5 mL from the large bottle on the remaining days of the week using a standardized spoon for 8 wk. Bottles had similar appearance Malaria endemicity not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Subjects were assigned at random to two groups. Method of sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants: were not aware of the treatment Personnel: all mothers received two small bottles (each 80 mL) and two large bottles (each 170 mL), each containing a syrup of similar appearance Outcome assessors: supervising staff were not aware of the bottle content. |
Incomplete outcome data (attrition bias) All outcomes | High risk | A complete set of data was obtained for 33 subjects in the group supplemented twice weekly (group 1) (75%) and for 32 subjects in the group supplemented daily (group 2) (74.4%). |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | High risk | Baseline haemoglobin concentrations were different between groups. The results include 25 children with Hb> 110 g/L and the initial description only mentions 16 |