Ermis 2002.
Methods | Randomised placebo‐controlled trial. 4‐arm design with individual randomisation. | |
Participants | 113 infants, both sexes (56 females (50%)), 5‐month old, receiving routine paediatric care at the Research hospital of Karaelmas University in Zonguldak, Turkey. Inclusion criteria: no gestational problems (hypertension, preeclampsia, infection), no congenital anomalies, no neonatal complications, no emergency caesarian delivery, no jaundice requiring phototherapy, no hospitalisation, no chronic illness, no iron therapy, no formula feeding. Must have been exclusively breasted, birthweight > 3.0 kg and gestational age of > 37 weeks. Exclusion: Hb < 95 g/L, serum ferritin <12 ng/mL, MCV < 74 fl or infection during iron supplementation. Children were eliminated from the study if compliance was lower than 75%. 58.6%‐74. Baseline prevalence of anaemia not reported. One percent of the mothers of participants included in the study graduated from high school or university. | |
Interventions | Infants were allocated to one of the following groups: Group 1 (n = 30): infants were given a supplement containing 1 mg iron/kg (as ferrous sulphate) daily; Group 2 (n = 30): infants were given a supplement of 2 mg iron/kg (as ferrous sulphate) daily; Group 3 (n = 30): infants were given a supplement of 2 mg iron/kg (as ferrous sulphate)) every other day (approximately 42 mg of iron per week); Group 4 (n = 23): infants received a placebo. Length of the intervention: 4 months. Groups 1 and 2 were combined and compared with group 3. |
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Outcomes | Haemoglobin, MCV, ferritin, side effects. | |
Notes | Supplements were given by mothers just before or just after breastfeeding and at least one hour before or after any other food intake. Malaria endemicity not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Children were randomised to the different groups. Method of sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants: Not reported. Personnel: Not reported. Outcome assessors: Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two, three and one cases were eliminated because of low compliance(<75%), in group 1, 2 and 3, respectively. The causes of non‐compliance were infection during iron usage, refusing iron droplets due to unpleasant taste, or mothers forgetting to use the iron drops. |
Selective reporting (reporting bias) | Unclear risk | Cases with less than 75% of adherence were excluded. |
Other bias | Unclear risk | Cases with less than 75% of adherence were excluded. It is unclear why the control group has 25% less participants. |