Lieden 1975.
| Methods |
Type of study: parallel, 2‐arm randomised controlled trial Country of study: Sweden Study setting: single Number of participants randomised: Treatment arm 1: 10 Treatment arm 2: 10 Number of participants analysed: Treatment arm 1: 10 Treatment arm 2: 7 Follow‐up time points: mean 36.4 (20 mg) or 24.5 (100 mg) days after third donation after baseline; mean 20.4 (20 mg) or 18.6 (100 mg) days after fifth donation after baseline. Mean interval 7.5 weeks between donations Hb threshold for deferral from donation: not reported Source of funding: supported by a grant from AB Astra, Sodertalje |
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| Participants | Young, male, first‐time donor conscripts Mean age (years): not reported Sex (male/female): 100%/0% |
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| Interventions | Treatment arm 1: oral ferrous carbonate (AB Astra), 100 mg stabilised with sugar in pellet form, taken daily for 1 year. Total dose: 36,500 mg Treatment arm 2: oral ferrous carbonate (AB Astra), 20 mg stabilised with sugar in pellet form, taken daily for 1 year. Total dose: 7300 mg |
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| Outcomes | Packed cell volume; serum iron; total iron binding capacity; stainable bone marrow iron; iron absorption; faecal iron | |
| 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 |
| 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 | 3 randomised participants withdrew from the study; all were in the same treatment group (20 mg ferrous carbonate) |
| 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 | Supported by AB Astra, manufacturer of ferrous carbonate |