Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/05/2007
Date assigned
02/08/2007
Last edited
29/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.riboflavin.group.shef.ac.uk

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

http://www.shef.ac.uk/

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

  1. 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.

Additional files

Editorial Notes