Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study

Completed

• Conditions: Single Nucleotide Polymorphism

• Registration Number: NCT00975364
• Lead Sponsor: Quadram Institute Bioscience

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between MTHFR TT, CT and CC genotype and red cell folate species	July 2010

Secondary Outcome Measures

Name	Time	Method
Relationship between other folate metabolism related genes and red cell folate species	July 2010
Relationship between folate, B12, riboflavin and ferritin status and red cell folate species	December 2010

Trial Locations

Locations (1)

Institute of Food Research; 🇬🇧 Norwich, Norfolk, United Kingdom