Folate Absorption Across the Large Intestine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 13C5-Calcium-L-Leucovorin

• Registration Number: NCT00941174
• Lead Sponsor: The Hospital for Sick Children

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

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 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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-30
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsule: 400 microg 13C5-Calcium-L-Leucovorin	13C5-Calcium-L-Leucovorin	-
IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin	13C5-Calcium-L-Leucovorin	-

Primary Outcome Measures

Name	Time	Method
Blood Folate - Study Period 1	Day 1 (Baseline), Day 2 (0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Blood Folate - Study Period 2	Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)
Urine Folate - Study Period 1	24h, 48h, 72h, 96h
Urine Folate - Study Period 2	24h, 48h, 72h

Secondary Outcome Measures

Name	Time	Method
Dietary Recall Records for folate analysis during urine collection days, Anthropometric.	Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4)

Trial Locations

Locations (1)

The Hospital For Sick Chidlren; 🇨🇦 Toronto, Ontario, Canada