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An investigation of the functional significance of marginal riboflavin status in young women
ISRCTN ISRCTN35811298
DOI 10.1186/ISRCTN35811298
ClinicalTrials.gov identifier
EudraCT number
Public title An investigation of the functional significance of marginal riboflavin status in young women
Scientific title
Acronym RiboFem
Serial number at source University Research Ref No.: 109242
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.
Lay summary
Ethics approval Approval received from the Sheffield University Research Ethics Committee on the 15th March 2006 (ref: SMBRER15).
Study design Randomised double-blind placebo controlled interventional trial
Countries of recruitment United Kingdom
Disease/condition/study domain Impaired handling of iron
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
2.1. coeliac disease
2.2. ulcerative colitis
2.3. Crohns disease
2.4. inflammatory bowel disease
3. Blood donors
4. Haemochromatosis
5. Pregnancy
Anticipated start date 01/04/2006
Anticipated end date 30/12/2007
Status of trial Completed
Patient information material Participant information sheet can be located at: http://www.riboflavin.group.shef.ac.uk/riboflavininfosheet.pdf
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.
Sources of funding Food Standards Agency (UK) (ref: N05061)
Trial website http://www.riboflavin.group.shef.ac.uk
Publications 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19323801
Contact name Prof  Hilary  Powers
  Address Human Nutrition Unit
School of Medicine & Biomedical Sciences
The University of Sheffield
Beech Hill Road
  City/town Sheffield
  Zip/Postcode S10 2RX
  Country United Kingdom
  Tel +44 (0)114 226 1346
  Email h.j.powers@sheffield.ac.uk
Sponsor University of Sheffield (UK)
  Address Research Office
New Spring Road
231 Glossop Road
  City/town Sheffield
  Zip/Postcode S10 2GW
  Country United Kingdom
  Tel +44 (0)114 222 1441
  Email research.office@sheffield.ac.uk
  Sponsor website: http://www.shef.ac.uk/
Date applied 25/05/2007
Last edited 29/09/2009
Date ISRCTN assigned 02/08/2007
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