Effect of Folic Acid on Primary Folate Forms in Relation... | NCT01105351

Studies
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR

NCT01105351

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

May 14, 2018Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

the Effect of MTHFR C677T on Folate Metabolism

Interventions

folic acid plus B6 and B12
folic acid

Countries

Germany

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

May 2018

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

Jun 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

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

May 7, 2018

Last Update Posted Date

May 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.

Detailed Description

The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
folic acid plus B6 and B12	Active Comparator	folic 400 µg plus vitamin B12 plus B6	Dietary Supplement: folic acid plus B6 and B12
Folic acid	Placebo Comparator	folic acid alone	Dietary Supplement: folic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
folic acid plus B6 and B12	Dietary Supplement	folic acid 400 µg plus vitamin B12 plus B6	folic acid plus B6 and B12

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood metabolic markers	we will measure primary folate forms after folic acid supplement	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females
Age > 65 years.

Exclusion Criteria:

Renal dysfunction
Recent stroke, or coronary event (within the last 3 months)
Current cancer treatment
Antifolate (e.g. methotrexate) treatment
Ileum resection
Current B-vitamin supplement
Epilepsy medications
Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rima Obeid, PhD	Department of Clinical Chemistry, University of Saarland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Saarland		Homburg	Saarland	66424	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25943647	Result	Obeid R, Kirsch SH, Dilmann S, Klein C, Eckert R, Geisel J, Herrmann W. Folic acid causes higher prevalence of detectable unmetabolized folic acid in serum than B-complex: a randomized trial. Eur J Nutr. 2016 Apr;55(3):1021-8. doi: 10.1007/s00394-015-0916-z. Epub 2015 May 6.

ID	Term
D005492	Folic Acid
D014805	Vitamin B 12

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring