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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00975364
Other study ID # IFR05/2008
Secondary ID 08/H0310/1532008
Status Completed
Phase N/A
First received September 10, 2009
Last updated February 15, 2013
Start date February 2009
Est. completion date December 2010

Study information

Verified date February 2013
Source Institute of Food Research
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

This pilot study is designed to investigate differences in folate-related genes (single nucleotide polymorphisms) and their relationship to the species of folate present on red blood cells.


Description:

The main questions to be addressed in this pilot study are:

1. what is the type of folate in red blood cells in individuals with different methylterahydrofolate reductase (MTHFR) genotypes

2. what is the relationship between other folate metabolism-related gene single nucleotide polymorphisms and type (species) of folate found in red blood cells

3. what is the relationship between folate and other B vitamin status, genotype and folate species

4. is there a relationship between serum ferritin status and folate metabolism

Whole blood will be taken from apparently healthy male and female volunteers, aged 18-65, which will be used to determine genotype for various folate metabolism-related genes. Furthermore, the type of folate present on the red blood cells will be assessed, and folate, vitamin B12, riboflavin and serum ferritin status determined.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged 18-65

- Males and females

- Body Mass Index greater than 19.5 and less than 40

- Smokers and non-smokers

Exclusion Criteria:

- Pregnancy or been pregnant in last 12 months

- Diabetes

- Parallel participation in another research project if total amount of blood from combined studies is greater than 470ml

- Participation in another research project where blood samples were taken within the past 4 months, unless total blood volume does not exceed 470ml

- Any person related to or living with a member of the study team

- Has donated or intends to donate blood within 16 weeks (prior to or after) the study

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Institute of Food Research Norwich Norfolk

Sponsors (1)

Lead Sponsor Collaborator
Institute of Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between MTHFR TT, CT and CC genotype and red cell folate species July 2010 No
Secondary Relationship between other folate metabolism related genes and red cell folate species July 2010 No
Secondary Relationship between folate, B12, riboflavin and ferritin status and red cell folate species December 2010 No
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