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Study Protocol: Randomised controlled trial to investigate the functional significance of marginal riboflavin status in young women in the UK (RIBOFEM)

Hill, M.H.E., Mushtaq, S., Williams, E.A., Dainty, J.R. and Powers, H.J. (2009) Study Protocol: Randomised controlled trial to investigate the functional significance of marginal riboflavin status in young women in the UK (RIBOFEM). BMC Public Health, 9 (1). p. 90. ISSN 1471-2458

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Abstract

BACKGROUND:

The functional significance of moderate riboflavin deficiency as it is currently assessed is not well understood. Animal and human studies have suggested a role for riboflavin in the absorption and mobilisation of iron and as such may be important in maintaining haematological status. Recent National Diet and Nutrition Surveys in the United Kingdom have shown that young women in particular are at risk of moderate riboflavin deficiency and low iron status.

METHODS/DESIGN:

A randomised placebo controlled intervention trial was conducted to investigate the effect of riboflavin supplementation on various measures of haematological status in a group of moderately riboflavin deficient young women aged 19 to 25 years. Women who were low milk consumers were initially screened for riboflavin status as assessed by the erythrocyte glutathione reductase activation coefficient assay (EGRAC). One hundred and twenty three women with EGRAC values >1.40 were randomised to receive 2 mg, 4 mg riboflavin or placebo for 8 weeks. In addition 36 of these women were randomly allocated to an iron bioavailability study to investigate the effect of the intervention on the absorption or utilisation of iron using an established red cell incorporation technique.

DISCUSSION:

One hundred and nineteen women completed the intervention study, of whom 36 completed the bioavailability arm. Compliance was 96 ± 6% (mean ± SD). The most effective recruitment strategy for this gender and age group was e-communication (e-mail and website). The results of this study will clarify the functional significance of the current biochemical deficiency threshold for riboflavin status and will inform a re-evaluation of this biochemical threshold.

Item Type: Article
Copyright, Publisher and Additional Information: © 2009 Hill et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Institution: The University of Sheffield
Academic Units: The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine (Sheffield) > Division of Genomic Medicine (Sheffield) > Department of Oncology (Sheffield)
Depositing User: Sheffield Import
Date Deposited: 05 Oct 2009 10:54
Last Modified: 08 Oct 2009 09:48
Published Version: http://www.biomedcentral.com/1471-2458/9/90
Status: Published
Publisher: Biomed Central
Identification Number: 10.1186/1471-2458-9-90
URI: http://eprints.whiterose.ac.uk/id/eprint/9665

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