Falahi 2010.
Methods | RCT, 2 arms with individual randomisation | |
Participants | 148 non‐anaemic pregnant women, 20‐35 years of age with gestational age less than 20 weeks, primigravidae, BMI less than 25 and less than 30 and Hb concentrations lower than 110 g/L and serum ferritin higher than 20 μg/L who visited the gynaecology centre in Khorramabad city, Lorestan Province, Western Iran. Participants who had diabetes mellitus, renal disease, coronary heart disease, or reported having used multivitamins and minerals, drugs or being on a special diet were excluded. | |
Interventions | Participants were randomly allocated to 1 of to groups:
group 1 (n = 70) received tablets containing 60 mg elemental iron (as ferrous sulphate);
group 2 (n = 78) received placebo tablets until delivery. Women who were anaemic or iron deficient were referred for medical evaluation and treated. Setting and heath worker cadre: the intervention was performed by physicians at a gynaecology centre in Khorramabad city, Lorestan Province, Western Iran. |
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Outcomes | Hb concentration, serum ferritin at baseline, week 28 and at delivery; birthweight, birth length, pregnancy duration. | |
Notes | Gestational age at start of supplementation: early gestational age (supplementation started less than 20 weeks' gestation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: high daily dose (60 mg elemental iron daily). Iron release formulation: normal release preparation/not specified. Iron compound: ferrous sulphate. Malaria setting: yes. As of 2011: Malaria risk due to P. vivax and P. falciparum exists from March to November inclusive in rural areas of the provinces of Hormozgan and Kerman (tropical part) and the southern part of Sistan‐Baluchestan. P. falciparum resistant to chloroquine and sulphadoxine–pyrimethamine reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Low risk | This was a placebo‐controlled trial. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as a triple‐blind trial, placebo‐controlled. Placebos described as indistinguishable from active supplements. It was stated that participants and staff were not aware of treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | It was stated that staff and analysts were not aware of treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 148 women were randomised. It was not clear whether any women were lost to follow‐up or if there were any missing data. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | Groups appeared comparable at baseline. |