Leonard 2014.
Methods |
Design: randomised controlled trial Randomisation: individual Trial: daily oral iron (two doses) versus placebo Date of study: 2010 to 2013 |
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Participants |
Setting: women recruited via flyer through the Hunter Medical Research Institute (Australia) Malaria endemicity: not stated Included: women aged 18 years to 35 years (mean age 26 years) with BMI between 18 kg/m² and 30 kg/m² and English speaking Excluded: iron deficient in last 12 months, taking iron, chronic medical condition or pregnant Dropouts: 12 out of 36 lost to follow‐up Sample size: total: 24; intervention: 16, control: 8 |
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Interventions |
Intervention: 60 mg or 80 mg elemental iron as ferrous sulphate Control: placebo Duration: 16 weeks |
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Outcomes | Haemoglobin, iron status, side effects and cognitive outcomes | |
Notes |
Compliance: on average 90.4% of capsules taken Conflicts of interest: authors declare no conflict of interest Funded by: Australian Post‐Graduate Award, Meat and Livestock Australia and the School of Health Sciences at the University of Newcastle |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator |
Allocation concealment (selection bias) | Low risk | Reports concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No evidence |
Incomplete outcome data (attrition bias) All outcomes | High risk | > 30% loss in many groups |
Selective reporting (reporting bias) | Low risk | Not evident |
Other bias | Low risk | Not evident |