Clinical trial NCT00941174: Folate Absorption Across the Large Intestine
Official title: Folate Absorption Across the Large Intestine, Study #2: Capsule Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: (13C5) Calcium Leucovorin
Folate absorption across the large intestine
Folate Bioavailability
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: University of Florida
First posted: 2009-07-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Blood Folate - Study Period 1
timeFrame: Day 1 (Baseline), Day 2 (0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
measure: Blood Folate - Study Period 2
timeFrame: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)
measure: Urine Folate - Study Period 1
timeFrame: 24h, 48h, 72h, 96h
measure: Urine Folate - Study Period 2
timeFrame: 24h, 48h, 72h
Secondary outcomes:
measure: Dietary Recall Records for folate analysis during urine collection days, Anthropometric.
timeFrame: Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital For Sick Chidlren
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Deborah O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lakoff A, Fazili Z, Aufreiter S, Pfeiffer CM, Connolly B, Gregory JF 3rd, Pencharz PB, O'Connor DL. Folate is absorbed across the human colon: evidence by using enteric-coated caplets containing 13C-labeled [6S]-5-formyltetrahydrofolate. Am J Clin Nutr. 2014 Nov;100(5):1278-86. doi: 10.3945/ajcn.114.091785. Epub 2014 Sep 3.