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Folate Absorption Across the Large Intestine

This study has been completed.
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
University of Florida
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00941174
First received: July 14, 2009
Last updated: July 16, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: 13C5-Calcium-L-Leucovorin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Folate Absorption Across the Large Intestine, Study #2: Capsule Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Blood Folate - Study Period 1 [ Time Frame: Day 1 (Baseline), Day 2 (0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr) ] [ Designated as safety issue: No ]
  • Blood Folate - Study Period 2 [ Time Frame: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h) ] [ Designated as safety issue: No ]
  • Urine Folate - Study Period 1 [ Time Frame: 24h, 48h, 72h, 96h ] [ Designated as safety issue: No ]
  • Urine Folate - Study Period 2 [ Time Frame: 24h, 48h, 72h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary Recall Records for folate analysis during urine collection days, Anthropometric. [ Time Frame: Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4) ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capsule: 400 microg 13C5-Calcium-L-Leucovorin Drug: 13C5-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.
Other Name: 13C5 Folate
Active Comparator: IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin Drug: 13C5-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.
Other Name: 13C5 Folate

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941174

Locations
Canada, Ontario
The Hospital For Sick Chidlren
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Centers for Disease Control and Prevention
University of Florida
Investigators
Principal Investigator: Deborah O'Connor, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Dr. Deborah O'Connor/ Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00941174     History of Changes
Other Study ID Numbers: 1000008487-2b
Study First Received: July 14, 2009
Last Updated: July 16, 2009
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
(13C5) Calcium Leucovorin
Folate absorption across the large intestine
Folate Bioavailability

Additional relevant MeSH terms:
Calcium, Dietary
Folic Acid
Vitamin B Complex
Leucovorin
Levoleucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Vitamins
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Therapeutic Uses
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013