NCT00975364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

September 10, 2009

Last Update Submit

February 15, 2013

Conditions

Single Nucleotide Polymorphism

Keywords

FolateMethylenetetrahydrofolate reductaseSpeciationNutrient statusBioavailabilityPolymorphism, single nucleotide

Outcome Measures

Primary Outcomes (1)

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

    July 2010

Secondary Outcomes (2)

  • 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

Study Arms (1)

blood sampling

Consented volunteers provide a one-off blood sample

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults (male and female) aged 18-65

You may qualify if:

  • Aged 18-65
  • Males and females
  • Body Mass Index greater than 19.5 and less than 40
  • Smokers and non-smokers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 6JF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

  • Paul Finglas

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

GB(1)