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. 2014 Jul 3;2014(7):CD009532. doi: 10.1002/14651858.CD009532.pub2

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
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%
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)
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