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. 2014 Jul 3;2014(7):CD009532. doi: 10.1002/14651858.CD009532.pub2

Gordeuk 1987a.

Methods Type of study: parallel, 3‐arm randomised controlled trial
Country of study: USA
Study setting: multi‐centre: 3 fixed site collection facilities
Number of participants randomised:
Treatment arm 1: 24
 Treatment arm 2: 26
 Treatment arm 3: 25
Number of participants analysed:
Treatment arm 1: 15
 Treatment arm 2: 17
 Treatment arm 3: 19
Follow‐up time points: day 56 after baseline donation
Hb threshold for deferral from donation: not reported (Hct 38%)
Source of funding: sponsored in part by Food and Drug Administration Orphan Drugs Development Grant
Participants Female donors of child‐bearing age with Hct ≥ 38% who had donated blood at least once previously
Mean age (years): not reported
Sex (male/female): 0%/100%
Interventions Treatment arm 1: oral carbonyl iron, 600 mg taken 3 times daily for 7 days. Total dose: 12,600 mg
Treatment arm 2: oral ferrous sulphate, 300 mg (60 mg Fe2+) taken 3 times daily for 7 days. Total dose: 1260 mg Fe2+
Treatment arm 3: oral placebo, taken 3 times daily for 7 days
Outcomes Haemoglobin; mean corpuscular volume; free erythrocyte protoporphyrin; serum ferritin; serum iron; total iron binding capacity; transferrin saturation; adverse effects
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of study participants was not reported although the study was described as "double‐blind" and identical capsules were used for both treatment and placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessors was not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk The number of withdrawals differed between treatment arms (9/26 versus 6/25)
Selective reporting (reporting bias) Unclear risk All outcomes listed in the manuscript were reported, but no study protocol was available to determine the full list of pre‐specified outcomes
Other bias Low risk No other sources of bias identified