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 protocolReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 10:4

First Online: 16 January 2009Received: 31 October 2008Accepted: 16 January 2009DOI: 10.1186-1745-6215-10-4

Cite this article as: Pedrazzini, B., Waldvogel, S., Cornuz, J. et al. Trials 2009 10: 4. doi:10.1186-1745-6215-10-4

Abstract

BackgroundThere 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 ≤ 30 ng-ml.

Methods-DesignIn 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 ≤ 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.

DiscussionIron 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.

Trial registrationNCT00689793

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-10-4 contains supplementary material, which is available to authorized users.

Baptiste Pedrazzini, Sophie Waldvogel contributed equally to this work.

Download fulltext PDF



Autor: Baptiste Pedrazzini - Sophie Waldvogel - Jacques Cornuz - Paul Vaucher - Raphael Bize - Jean-Daniel Tissot - Alain Pecoud -

Fuente: https://link.springer.com/







Documentos relacionados