Ehn 1968.
Methods |
Type of study: parallel, 3‐arm randomised controlled trial Country of study: Sweden Study setting: single centre Number of participants randomised: not reported Number of participants analysed: (after 4 donations): Treatment arm 1: 12 Treatment arm 2: 12 Treatment arm 3: 18 Follow‐up time points: 2 months after 6 donations subsequent to baseline donation; inter‐donation interval of 2 months Hb threshold for deferral from donation: not reported Source of funding: supported by AB Hassle, Molndal Medical Research Fund, County of Ostergotland |
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Participants | Young male first‐time donor conscripts Mean age (years): both arms combined (subset of 58 subjects): mean 20, range 18 to 23 Sex (male/female): 100%/0% |
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Interventions | Treatment arm 1: oral iron (Ferromyn S, AB Hassle); 37 mg as ferrous succinate + 0.11 g succinic acid taken as 2 tablets twice daily for 2 weeks. Total dose: 2000 mg Treatment arm 2: oral iron (Ferromyn S, AB Hassle); 37 mg as ferrous succinate + 0.11 g succinic acid taken twice daily for 2 weeks. Total dose: 1000 mg Treatment arm 3: oral placebo taken twice daily |
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Outcomes | Haemoglobin; serum iron, total iron binding capacity; stainable bone marrow iron; sideroblasts; desferrioxamine test | |
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 | Unclear risk | Blinding of study participants was not reported although a placebo was used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors was not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some withdrawals were described but the number of participants randomised to each treatment arm was not reported |
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 | High risk | The study was supported by AB Hassle, manufacturers of iron supplements |