NCT03305900

Brief Summary

Formate is an important metabolite, serving as a donor of one-carbon groups to the intracellular tetrahydrofolate pool. However, little is known of its circulating concentrations or of their determinants. This study seeks to define formate levels and their determinants in a young, healthy population. Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate levels will be compared with other one-carbon metabolites, vitamin status, potential formate precursors, genetic polymorphisms, and lifestyle factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

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

December 1, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

September 28, 2017

Last Update Submit

October 4, 2017

Conditions

Healthy

Keywords

formateone-carbon metabolism

Outcome Measures

Primary Outcomes (1)

  • Formate concentrations

    Formate concentrations in study population

    Single baseline measurement; cross sectional, observational study

Interventions

No InterventionOTHER

Cross-sectional study requiring a single serum sample

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Serum formate was measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin

You may qualify if:

  • Trinity College Dublin students with Irish grandparents

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Brosnan JT, Mills JL, Ueland PM, Shane B, Fan R, Chiu CY, Pangilinan F, Brody LC, Brosnan ME, Pongnopparat T, Molloy AM. Lifestyle, metabolite, and genetic determinants of formate concentrations in a cross-sectional study in young, healthy adults. Am J Clin Nutr. 2018 Mar 1;107(3):345-354. doi: 10.1093/ajcn/nqx065.

    PMID: 29566195DERIVED

Study Officials

  • Anne Molloy, Ph.D.

    University of Dublin, Trinity College

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biochemistry

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 10, 2017

Study Start

December 1, 2012

Primary Completion

November 26, 2013

Study Completion

November 26, 2013

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share