Bioavailability of Folic Acid Fortified Bread | NCT01570088

Studies
Bioavailability of Folic Acid Fortified Bread

NCT01570088

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Dec 16, 2014Estimated

Enrollment

45Actual

Phase

Phase 2

Conditions

Red Blood Cell Folate

Interventions

Folic acid
L-5-MTHF
Placebo

Countries

Canada

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

Dec 2014

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

Apr 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 30, 2012

First Posted Date

Apr 4, 2012Estimated

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

Dec 12, 2014

Last Update Posted Date

Dec 16, 2014Estimated

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

Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.

The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.

Detailed Description

See above.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Folic acid	Active Comparator	Dietary Supplement: Folic acid
L-5-MTHF	Experimental	Dietary Supplement: L-5-MTHF
Placebo	Placebo Comparator	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Folic acid	Dietary Supplement	One roll/bun per day fortified with 400 µg of folic acid	Folic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
red blood cell folate concentration at three time points	We will take one blood sample at baseline, 8th and 16th week. For each blood sample, we will measure the red blood cell folate concentration as our primary outcome measure. We will record the changes in the folate concentrations.	baseline, 8th week, 16th week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-45 years
Not taking a folic acid containing supplement

Exclusion Criteria:

Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness
Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate)
Adults with wheat, milk allergy or lactose intolerance
Adults with known B12 deficiency
Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits)
Women have been pregnant during the year previous
Women planning a pregnancy in the next year
Women who believe they may become pregnant during the study
Women who have had a known previous neural tube defect affected pregnancy
Adults who are unable to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Green, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of British Columbia		Vancouver	British Columbia	V6T 1Z4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23616513	Derived	Green TJ, Liu Y, Dadgar S, Li W, Bohni R, Kitts DD. Wheat rolls fortified with microencapsulated L-5-methyltetrahydrofolic acid or equimolar folic acid increase blood folate concentrations to a similar extent in healthy men and women. J Nutr. 2013 Jun;143(6):867-71. doi: 10.3945/jn.113.174268. Epub 2013 Apr 24.

ID	Term
D005492	Folic Acid
C005984	5-methyltetrahydrofolate

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