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29 August 2008
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| An investigation of the functional significance of marginal riboflavin status in young women |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN35811298 |
| Date ISRCTN assigned | 02/08/2007 |
| Local reference number(s) | University Research Ref No.: 109242 |
| Public title | An investigation of the functional significance of marginal riboflavin status in young women |
| Scientific title | |
| Acronym | RiboFem |
| Disease/condition/study domain | Impaired handling of iron |
| Study hypothesis | National Diet and Nutrition Surveys show that in certain groups of the population there is a high proportion of people with biochemical evidence of poor riboflavin status. The functional significance of this is not clear. We will examine the hypothesis that marginal riboflavin status is associated with impaired handling of iron. The results will help to clarify the functional significance of marginal riboflavin status and inform debate regarding dietary recommendations for this nutrient. |
| Design/methodology | Randomised, double-blind, placebo controlled interventional trial. |
| Research ethics review | Approval received from the Sheffield University Research Ethics Committee on the 15th March 2006 (ref: SMBRER15). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Women aged 19 to 25 years 2. Low milk consumption (less than 200 ml a day) 3. Healthy 4. Marginal riboflavin deficiency as measured by an Erythrocyte Glutathione Reductase Activation Coefficient of greater than 1.4 |
| Participants - exclusion criteria | 1. Use of multivitamin or iron supplements (within last three months) 2. Diagnosed gastrointestinal disorders: coeliac disease, ulcerative colitis, Crohns disease or inflammatory bowel disease 3. Blood donors 4. Haemochromatosis 5. Pregnancy |
| Patient information material | Participant information sheet can be located at: http://www.riboflavin.group.shef.ac.uk/riboflavininfosheet.pdf |
| Anticipated start date | 01/04/2006 |
| Anticipated end date | 30/12/2007 |
| Status of trial | Completed |
| Target number of participants | 120 |
| Interventions | Main study: Three intervention groups: 1. 2 mg riboflavin for eight weeks 2. 4 mg riboflavin for eight weeks 3. Placebo for eight weeks Bioavailability study: 32 volunteers from the main study randomly assigned to participate in additional bioavailability study involving consumption of special meals two weeks before and immediately after the main study. These meals will contain a stable isotope of iron (Fe58). |
| Primary outcome measure(s) | Main study, measured at baseline and after eight weeks intervention: 1. Measures of iron and haematological status: 1.1. Ferritin 1.2. Haemoglobin 1.3. Mean Corpuscular Volume (MCV) 1.4. Mean Corpuscular Haemoglobin Concentration (MCHC) 1.5. Red Blood Cells (RBC) 1.6. Haematocrit 1.7. Zinc Protoporphyrin (ZPP) 1.8. Soluble Transferrin Receptor (sTFR) Bioavailability study, additional outcomes measured at baseline and two weeks after dose of isotopic iron (repeated on two separate occasions before and after main study): Incorporation of Fe58 into erythrocytes. |
| Secondary outcome measure(s) | Lowering of plasma homocysteine. |
| Trial website | http://www.riboflavin.group.shef.ac.uk |
| Sources of funding | Food Standards Agency (UK) (ref: N05061) |
| Sponsor name | University of Sheffield (UK) |
| Sponsor details | Research Office New Spring Road 231 Glossop Road Sheffield United Kingdom S10 2GW |
| Sponsor telephone | +44 (0)114 222 1441 |
| Sponsor email | research.office@sheffield.ac.uk |
| Sponsor website | http://www.shef.ac.uk/ |
| Contact name | Prof Hilary Powers |
| Contact details | Human Nutrition Unit School of Medicine & Biomedical Sciences The University of Sheffield Beech Hill Road Sheffield United Kingdom S10 2RX |
| Contact telephone | +44 (0)114 226 1346 |
| Contact email | h.j.powers@sheffield.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN35811298 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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