Blot 1980.
Methods |
Type of study: parallel, 2‐arm randomised controlled trial Country of study: France Study setting: single transfusion centre Number of participants randomised: Treatment arm 1: 91 Treatment arm 2: 80 Number of participants analysed: Treatment arm 1: 73 (42 male, 31 female) Treatment arm 2: 70 (43 male, 27 female) Follow‐up time points: first donation after baseline donation Hb threshold for deferral from donation: not reported Source of funding: not reported |
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Participants | Regular donors (at least 1 prior donation) Mean age (years): combined treatment arms: 36.4 (SD 9.5, range 20 to 59) (male); 34.1 (SD 10.8, range 18 to 56) (female) Sex (male/female): 57.3%/62.7% |
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Interventions | Treatment arm 1: oral iron and ascorbic acid (Fero‐Grad Abbott); 105 mg iron and 500 mg ascorbic acid taken daily in the morning Total dose: 3150 mg per month Treatment arm 2: control (no iron supplementation or placebo) |
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Outcomes | Haemoglobin; MCV; total serum iron; total iron binding capacity; serum ferritin | |
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 | High risk | Study participants were not blinded |
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 (18/91 versus 10/80) and 10.5% of randomised participants were lost to follow‐up |
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 |