Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hilary Powers
ORCID ID
Contact details
Human Nutrition Unit
School of Medicine & Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
+44 (0)114 226 1346
h.j.powers@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
University Research Ref No.: 109242
Study information
Scientific title
Acronym
RiboFem
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Participant information sheet can be located at: http://www.riboflavin.group.shef.ac.uk/riboflavininfosheet.pdf
Condition
Impaired handling of iron
Intervention
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).
Intervention type
Drug
Phase
Not Specified
Drug names
Riboflavin
Primary outcome measures
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 measures
Lowering of plasma homocysteine.
Overall trial start date
01/04/2006
Overall trial end date
30/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant 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
Recruitment start date
01/04/2006
Recruitment end date
30/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
Research Office
New Spring Road
231 Glossop Road
Sheffield
S10 2GW
United Kingdom
+44 (0)114 222 1441
research.office@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Food Standards Agency (UK) (ref: N05061)
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19323801
Publication citations
-
Protocol
Hill MH, Mushtaq S, Williams EA, Dainty JR, Powers HJ, Study Protocol: randomised controlled trial to investigate the functional significance of marginal riboflavin status in young women in the UK (RIBOFEM)., BMC Public Health, 2009, 9, 90, doi: 10.1186/1471-2458-9-90.