Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study (FolGene)

February 15, 2013 updated by: Quadram Institute Bioscience

Pilot Study to Investigate Relationship Between Common Folate Gene Polymorphisms, Folate Status and Cellular Folate Speciation

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 6JF
        • Institute of Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults (male and female) aged 18-65

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
blood sampling
Consented volunteers provide a one-off blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship between MTHFR TT, CT and CC genotype and red cell folate species
Time Frame: July 2010
July 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between other folate metabolism related genes and red cell folate species
Time Frame: July 2010
July 2010
Relationship between folate, B12, riboflavin and ferritin status and red cell folate species
Time Frame: December 2010
December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadram Institute Bioscience

Investigators

  • Principal Investigator: Paul Finglas, Quadram Institute Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IFR05/2008
  • 08/H0310/153
  • 2008IFR01L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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