Hinton 2007.
Methods |
Design: randomised controlled trial Randomisation: individual Trial: daily oral iron versus placebo Date of study: not stated |
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Participants |
Setting: recruited from University of Missouri Colombia (USA) and surrounding community via fliers and newspaper advertisements Malaria endemicity: not stated Included: 17 women and 3 men, aged 18 years to 41 years (mean age 28 years). Participants were iron deficient (serum ferritin < 16 mg/L; serum transferrin receptor > 48.0 mg/L; or transferrin receptor/log ferritin index > 44.5) and non‐anaemic (haemoglobin > 120 g/L for women; > 130 g/L for men) Excluded: current pregnancy or pregnancy within the previous year, recent infectious illness or fever, chronic inflammatory diseases, haemolytic anaemia, musculoskeletal problems, history of eating disorders, smoking, or consumption of iron supplements or medications that may interfere with dietary iron absorption or that have anticoagulant properties Dropouts: no reported dropouts Sample size: total: 20; intervention: 10, control: 10 |
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Interventions |
Intervention: ferrous sulphate equivalent to 30 mg elemental iron Control: placebo Duration: 6 weeks |
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Outcomes | Haemoglobin, iron status, exercise performance, fat mass, height, weight | |
Notes |
Compliance: on average, participants in the iron group ingested 98 (±8.2)% and the placebo group 99 (±5.4)% of their supplements. There was no significant difference in compliance between the two groups Conflicts of interest: trial authors report no conflict of interest Funded by: no funding reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method for sequence generation not stated |
Allocation concealment (selection bias) | Unclear risk | Method for allocation concealment not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo administered |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Measurement of exercise performance may be influenced by knowledge of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition |
Selective reporting (reporting bias) | Low risk | Not evident |
Other bias | Low risk | The study appears free of other sources of bias |