Gordeuk 1990.
| Methods |
Type of study: parallel, 2‐arm randomised controlled trial Country of study: USA Study setting: multiple fixed site blood donor centres Number of participants randomised: Treatment arm 1: 50 Treatment arm 2: 49 Number of participants analysed: Treatment arm 1: 40 Treatment arm 2: 36 Follow‐up time points: day 56 after baseline donation Hb threshold for deferral from donation: 125 g/L (Hct 38%) Source of funding: supported in part by Food and Drug Administration Orphan Drugs Development Grant and by National Heart, Lung and Blood Institute of the National Institutes of Health |
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| Participants | Female repeat donors with Hb ≥ 125 g/L Mean age (years): not reported (range 18 to 40) Sex (male/female): 0%/100% |
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| Interventions | Treatment arm 1: oral carbonyl iron (100 mg elemental iron) taken daily for 56 days. Total dose: 5600 mg Treatment arm 2: oral placebo, taken daily for 56 days |
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| Outcomes | Haemoglobin; haematocrit; MCV; serum ferritin; free red cell protoporphyrin; serum iron; total iron binding capacity; transferrin saturation; net iron absorption; 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 arms |
| 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 participants lost to follow‐up was high (30%) and differed between treatment arms (10/50 versus 13/49) |
| 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 |