Status:
COMPLETED
Folate Absorption Across the Large Intestine
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Centers for Disease Control and Prevention
University of Florida
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objective of this study is to determine whether the intact human colon with an unaltered microflora distribution absorbs folate and to what extent it is absorbed into the systemic circulation usin...
Detailed Description
This study supplements two earlier in print exploratory studies investigating the absorption of folate across the colon after an infusion during colonoscopy and a pre-trial with the purpose of determi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy adults
- Age 18-65 years
- Exclusion Criteria
- \<18 years of age, \>65 years of age
- chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, hematological, or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. anti-acid or nonsteroidal anti-inflammatory drugs \[NSAIDS\] such as aspirin/ibuprofen, phenytoin, sulfasalazine, phenobarbital, primidone, and cimetidine)
- regularly consume \> 1 drink of alcohol/d or current smoking (last 6 months)
- planning a pregnancy, pregnant, breast feeding or the use of high-dose oral contraceptives/hormone replacement therapy
- known sensitivity to Calcium Leucovorin
- 130mL of blood is \> 5% of total blood volume
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00941174
Start Date
September 1 2008
End Date
March 1 2009
Last Update
December 31 2013
Active Locations (1)
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1
The Hospital For Sick Chidlren
Toronto, Ontario, Canada