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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT00975364
First received: September 10, 2009
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition
Single Nucleotide Polymorphism

Study Type: Observational
Official Title: Pilot Study to Investigate Relationship Between Common Folate Gene Polymorphisms, Folate Status and Cellular Folate Speciation

Resource links provided by NLM:


Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Relationship between MTHFR TT, CT and CC genotype and red cell folate species [ Time Frame: July 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between other folate metabolism related genes and red cell folate species [ Time Frame: July 2010 ] [ Designated as safety issue: No ]
  • Relationship between folate, B12, riboflavin and ferritin status and red cell folate species [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

One-off blood sample collected. DNA extracted for genotyping of folate metabolism-related gene single nucleotide polymorphisms


Enrollment: 100
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
blood sampling
Consented volunteers provide a one-off blood sample

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adults (male and female) aged 18-65

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975364

Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 6JF
Sponsors and Collaborators
Institute of Food Research
Investigators
Principal Investigator: Paul Finglas Institute of Food Research
  More Information

No publications provided

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT00975364     History of Changes
Other Study ID Numbers: IFR05/2008, 08/H0310/153, 2008IFR01L
Study First Received: September 10, 2009
Last Updated: February 15, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Institute of Food Research:
Folate
Methylenetetrahydrofolate reductase
Speciation
Nutrient status
Bioavailability
Polymorphism, single nucleotide

Additional relevant MeSH terms:
Vitamin B Complex
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014