Folate Absorption Across the Large Intestine

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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 using a dual/oral intravenous route. This will elicit an understanding of colonic folate absorption and metabolism.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborators: Centers for Disease Control and Prevention; University of Florida
• Treatments: Calcium; Calcium, Dietary; Folic Acid; Leucovorin; Levoleucovorin; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Healthy adults

2. Age 18-65 years

Exclusion Criteria

1. <18 years of age, >65 years of age

2. chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, hematological, or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism

3. 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)

4. regularly consume > 1 drink of alcohol/d or current smoking (last 6 months)

5. planning a pregnancy, pregnant, breast feeding or the use of high-dose oral contraceptives/hormone replacement therapy

6. known sensitivity to Calcium Leucovorin

7. 130mL of blood is > 5% of total blood volume