The impact of iron supplementation efficiency in female blood donors with a decreased ferritin level and no anaemia. Rationale and design of a randomised controlled trial: a study protocol.
BACKGROUND
There is no recommendation to screen ferritin level in blood donors, even though several studies have noted the high prevalence of iron deficiency after blood donation, particularly among menstruating females. Furthermore, some clinical trials have shown that non-anaemic women with unexplained fatigue may benefit from iron supplementation. Our objective is to determine the clinical effect of iron supplementation on fatigue in female blood donors without anaemia, but with a mean serum ferritin < or = 30 ng/ml.


METHODS
In a double blind randomised controlled trial, we will measure blood count and ferritin level of women under age 50 yr, who donate blood to the University Hospital of Lausanne Blood Transfusion Department, at the time of the donation and after 1 week. One hundred and forty donors with a ferritin level < or = 30 ng/ml and haemoglobin level >/= 120 g/l (non-anaemic) a week after the donation will be included in the study and randomised. A one-month course of oral ferrous sulphate (80 mg/day of elemental iron) will be introduced vs. placebo. Self-reported fatigue will be measured using a visual analogue scale. Secondary outcomes are: score of fatigue (Fatigue Severity Scale), maximal aerobic power (Chester Step Test), quality of life (SF-12), and mood disorders (Prime-MD). Haemoglobin and ferritin concentration will be monitored before and after the intervention.


CONCLUSIONS
Iron deficiency is a potential problem for all blood donors, especially menstruating women. To our knowledge, no other intervention study has yet evaluated the impact of iron supplementation on subjective symptoms after a blood donation.


BACKGROUND
NCT00689793.
Pedrazzini
Baptiste
B
Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland. baptiste.pedrazzini@chuv.ch
Waldvogel
Sophie
S
Cornuz
Jacques
J
Vaucher
Paul
P
Bize
Raphael
R
Tissot
Jean-Daniel
JD
Pecoud
Alain
A
Favrat
Bernard
B
D000284:Administration, Oral; D000339:Affect / Q000187:drug effects; D015415:Biomarkers / Q000097:blood; D001782:Blood Donors; D019587:Dietary Supplements; D004311:Double-Blind Method; D015536:Down-Regulation; D017079:Exercise Tolerance / Q000187:drug effects; D005221:Fatigue / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005293:Ferritins / Q000097:blood*; D005296:Ferrous Compounds / Q000008:administration & dosage*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D000090463:Iron Deficiencies; D008875:Middle Aged; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D015415:Biomarkers; D005296:Ferrous Compounds; D006454:Hemoglobins; C020748:ferrous sulfate; D005293:Ferritins