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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35811298
Enrollment
120
Registered
2007-08-02
Start date
2006-04-01
Completion date
Unknown
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired handling of iron Nutritional, Metabolic, Endocrine Disorders of mineral metabolism

Interventions

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 rand

Sponsors

University of Sheffield (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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;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

Exclusion criteria

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;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

Design outcomes

Primary

MeasureTime frame
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.;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

MeasureTime frame
Lowering of plasma homocysteine.;Lowering of plasma homocysteine.

Countries

United Kingdom

Contacts

Public Contact; ;

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026