Folate Absorption Across the Large Intestine

The Hospital for Sick Children

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 13C5-Calcium-L-Leucovorin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00941174

1000008487-2b

Details and patient eligibility

About

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.

Full 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 determining dissolution characteristics of two placebo caplet formulations. Using a dual route oral/intravenous, folate (pharmaceutical name Calcium Leucovorin), labeled with a stable isotope will be used to quantitatively measure total folate levels, as well as the uptake of (13C) labeled folate. A pH dependent caplet targeted to the colon and fluoroscopy will determine dissolution characteristics. Labeled and unlabelled folate in blood and urine samples will be used to quantitatively measure the uptake of folate. This will further our understanding of the kinetics (caplet transit times), colonic folate absorption (metabolism) and impact on folate status (bioavailability) in healthy adults.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Capsule: 400 microg 13C5-Calcium-L-Leucovorin

Active Comparator group

Treatment:

Drug: 13C5-Calcium-L-Leucovorin

IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin

Active Comparator group

Treatment:

Drug: 13C5-Calcium-L-Leucovorin