Skip to main content
. 2014 Jul 3;2014(7):CD009532. doi: 10.1002/14651858.CD009532.pub2

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
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%
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
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