An investigation of the functional significance of marginal riboflavin status in young women

ISRCTN ISRCTN35811298
DOI https://doi.org/10.1186/ISRCTN35811298
Secondary identifying numbers University Research Ref No.: 109242
Submission date
25/05/2007
Registration date
02/08/2007
Last edited
11/01/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Hilary Powers
Scientific

Human Nutrition Unit
School of Medicine & Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Phone +44 (0)114 226 1346
Email h.j.powers@sheffield.ac.uk

Study information

Study designRandomised double-blind placebo controlled interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Participant information sheet Participant information sheet can be located at: http://www.riboflavin.group.shef.ac.uk/riboflavininfosheet.pdf
Scientific titleAn investigation of the functional significance of marginal riboflavin status in young women
Study acronymRiboFem
Study objectivesNational 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(s)Approval received from the Sheffield University Research Ethics Committee on the 15th March 2006 (ref: SMBRER15).
Health condition(s) or problem(s) studiedImpaired handling of iron
InterventionMain 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Riboflavin
Primary outcome measureMain 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 measuresLowering of plasma homocysteine.
Overall study start date01/04/2006
Completion date30/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/04/2006
Date of final enrolment30/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

Research Office
New Spring Road
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom

Phone +44 (0)114 222 1441
Email research.office@sheffield.ac.uk
Website http://www.shef.ac.uk/
ROR logo "ROR" https://ror.org/05krs5044

Funders

Funder type

Government

Food Standards Agency (UK) (ref: N05061)
Private sector organisation / Other non-profit organizations
Alternative name(s)
The Food Standards Agency, FSA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/03/2009 Yes No
Results article results 01/06/2011 Yes No

Editorial Notes

11/01/2018: publication reference added.