Healthy
Conditions
Keywords
(13C5) Calcium Leucovorin, Folate absorption across the large intestine, Folate Bioavailability
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.
Interventions
DRUG13C5-Calcium-L-Leucovorin
This drug will be used in a clinical trial the objective of which is to determine whether, and to what extent, a physiological concentration of natural folate is absorbed across the large intestine with an intact microflora.
Sponsors
Centers for Disease Control and Prevention
University of Florida
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Canada
Outcome results
None listed