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Folate Absorption Across the Large Intestine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941174
First Posted: July 17, 2009
Last Update Posted: December 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Disease Control and Prevention
University of Florida
Information provided by (Responsible Party):
Deborah O'Connor, The Hospital for Sick Children
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Folate Absorption Across the Large Intestine, Study #2: Capsule Study

Resource links provided by NLM:


Further study details as provided by Deborah O'Connor, 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) ]
  • Blood Folate - Study Period 2 [ Time Frame: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h) ]
  • Urine Folate - Study Period 1 [ Time Frame: 24h, 48h, 72h, 96h ]
  • Urine Folate - Study Period 2 [ Time Frame: 24h, 48h, 72h ]

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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah O'Connor, Associate Chief, Clinical Dietetics, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00941174     History of Changes
Other Study ID Numbers: 1000008487-2b
First Submitted: July 14, 2009
First Posted: July 17, 2009
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Deborah O'Connor, 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
Hematinics
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents