Status:
UNKNOWN
Assessing Colonic Folate Absorption & Metabolism
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Natural Sciences and Engineering Research Council, Canada
Conditions:
Folate
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Folate, a B-vitamin, is necessary in metabolic processes such as amino acid and nucleotide synthesis. Since folate cannot be synthesized by mammals, it must be consumed as foods and dietary supplement...
Detailed Description
The vitamin folate is necessary for one-carbon metabolism in processes such as amino acid and nucleotide synthesis. As folate cannot be synthesized by mammals, it must be sourced from the diet and die...
Eligibility Criteria
Inclusion
- Males \>18 years old and \<75 years old;
- Females who are pre-menopausal that have had a hysterectomy or tubal ligation, post-menopausal (at least 1 year) and \<75 years old;
- Describe themselves as generally healthy.
- Recommended to have a colonoscopy examination by their Doctor
Exclusion
- They have a history of gastrointestinal disease (such as Crohn's disease, ulcerative colitis, celiac disease) and/ or gastrointestinal cancers;
- They have had a previous colon resection;
- They are regularly using medications that may affect gastrointestinal pH or folate metabolism (e.g. proton pump inhibitors, phenytoin, phenobarbital, primidone, or have used oral antibiotics within the last 2 weeks);
- On a regular basis they consume \>2 alcoholic drinks/day for women or \>3/day for men;
- They are currently smokers;
- They are folic acid supplement users or have used folic acid supplements or multivitamins containing folic acid in the last 4 months;
- They have a bleeding disorder (such as hemophilia)
- They are unlikely able to discontinue anti-coagulant therapy prior to colonoscopy
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03421483
Start Date
December 17 2018
End Date
October 15 2023
Last Update
October 26 2022
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8