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Completed

NCT Number: NCT00975364

Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study

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.

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Key information

Conditions

Single Nucleotide Polymorphism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Food Research

Norwich, Norfolk, NR4 6JF, United Kingdom

About this study

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

  • what is the type of folate in red blood cells in individuals with different methylterahydrofolate reductase (MTHFR) genotypes
  • what is the relationship between other folate metabolism-related gene single nucleotide polymorphisms and type (species) of folate found in red blood cells
  • what is the relationship between folate and other B vitamin status, genotype and folate species
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Relationship between MTHFR TT, CT and CC genotype and red cell folate species

    Time frame: July 2010

Secondary outcomes

  1. Relationship between other folate metabolism related genes and red cell folate species

    Time frame: July 2010

  2. Relationship between folate, B12, riboflavin and ferritin status and red cell folate species

    Time frame: December 2010

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Registry information

Official study title

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

Acronym: FolGene

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 11, 2009
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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