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 |