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

ISRCTN	ISRCTN35811298
DOI	https://doi.org/10.1186/ISRCTN35811298
Protocol serial number	University Research Ref No.: 109242
Sponsor	University of Sheffield (UK)
Funder	Food Standards Agency (UK) (ref: N05061)

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

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

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Riboflavin
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.
Key secondary outcome measure(s)	Lowering of plasma homocysteine.
Completion date	30/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Human Nutrition Unit

Sheffield
S10 2RX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011		Yes	No
Protocol article	protocol	26/03/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/01/2018: publication reference added.