Determinants of Formate Concentrations | NCT03305900

Studies
Determinants of Formate Concentrations

NCT03305900

Sponsor

Memorial University of Newfoundland

Status

Completed

Last Update Posted

Oct 10, 2017Actual

Enrollment

1,701Actual

Phase

Not provided

Conditions

Healthy

Interventions

No Intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2012Actual

Primary Completion Date

Nov 26, 2013Actual

Completion Date

Nov 26, 2013Actual

First Submitted Date

Sep 28, 2017

First Submission Date that Met QC Criteria

Oct 4, 2017

First Posted Date

Oct 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2017

Last Update Posted Date

Oct 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John (Sean) Brosnan, Professor of Biochemistry, Memorial University of NewfoundlandPrincipal Investigator

Lead Sponsor

Memorial University of NewfoundlandOTHER

Collaborators

Name	Class
University of Dublin, Trinity College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,701Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	Cross-sectional study requiring a single serum sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Formate concentrations	Formate concentrations in study population	Single baseline measurement; cross sectional, observational study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Trinity College Dublin students with Irish grandparents

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

28 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Molloy, Ph.D.	University of Dublin, Trinity College	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29566195	Derived	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.