Single Nucleotide PolymorphismFolGeneNCT00975364
Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study
An observational study of Single Nucleotide Polymorphism, run by Quadram Institute Bioscience at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Nucleotide Polymorphism
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults (male and female) aged 18-65
Who may be able to join
- Aged 18-65
- Males and females
- Body Mass Index greater than 19.5 and less than 40
- Smokers and non-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 6JF
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Single Nucleotide Polymorphism
- Keywords
- Folate, Methylenetetrahydrofolate reductase, Speciation, Nutrient status, Bioavailability, Polymorphism, single nucleotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| blood sampling | Consented volunteers provide a one-off blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between MTHFR TT, CT and CC genotype and red cell folate species
Measured: July 2010
Secondary outcomes (2)
Relationship between other folate metabolism related genes and red cell folate species
Measured: July 2010
Relationship between folate, B12, riboflavin and ferritin status and red cell folate species
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Nucleotide PolymorphismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Finglas, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975364
- Sponsor's protocol ID
- IFR05/2008
- Other IDs
- 08/H0310/153, 2008IFR01L
- Acronym
- FolGene
- Status last verified
- Feb 2013
- First submitted
- 10 Sep 2009
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Relationship Between Common Folate Gene Polymorphisms, Folate Status and Cellular Folate Speciation
- ClinicalTrials.gov ID
- NCT00975364
- Acronym / sponsor ID
- FolGene / IFR05/2008
- Conditions
- Single Nucleotide Polymorphism
- Keywords
- Folate, Methylenetetrahydrofolate reductase, Speciation, Nutrient status, Bioavailability, Polymorphism, single nucleotide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sampling | – | –Consented volunteers provide a one-off blood sample |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults (male and female) aged 18-65
Key inclusion criteria (4 listed)
- Aged 18-65
- Males and females
- Body Mass Index greater than 19.5 and less than 40
- Smokers and non-smokers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between MTHFR TT, CT and CC genotype and red cell folate species
Time frame: July 2010
2 secondary outcomes
Relationship between other folate metabolism related genes and red cell folate species
Time frame: July 2010
Relationship between folate, B12, riboflavin and ferritin status and red cell folate species
Time frame: December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Finglas principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Nucleotide Polymorphism, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between MTHFR TT, CT and CC genotype and red cell folate species (time frame: July 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.