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
Contact information
Prof Hilary Powers
Scientific
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 |
|---|---|
| h.j.powers@sheffield.ac.uk |
Study information
| Study design | Randomised double-blind placebo controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Participant information sheet | Participant information sheet can be located at: http://www.riboflavin.group.shef.ac.uk/riboflavininfosheet.pdf |
| Scientific title | An investigation of the functional significance of marginal riboflavin status in young women |
| Study acronym | RiboFem |
| Study objectives | 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(s) | Approval received from the Sheffield University Research Ethics Committee on the 15th March 2006 (ref: SMBRER15). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Riboflavin |
| Primary outcome measure | 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 study start date | 01/04/2006 |
| Completion date | 30/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 30/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Human Nutrition Unit
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Sponsor information
University of Sheffield (UK)
University/education
University/education
Research Office
New Spring Road
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
| Phone | +44 (0)114 222 1441 |
|---|---|
| research.office@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N05061)
Private sector organisation / Other non-profit organizations
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
