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Completed

NCT Number: NCT00941174

Folate Absorption Across the Large Intestine

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Hospital For Sick Chidlren

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults
  • Age 18-65 years

Exclusion criteria

  • <18 years of age, >65 years of age
  • chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, hematological, or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
  • 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)
  • regularly consume > 1 drink of alcohol/d or current smoking (last 6 months)
  • planning a pregnancy, pregnant, breast feeding or the use of high-dose oral contraceptives/hormone replacement therapy
  • known sensitivity to Calcium Leucovorin
  • 130mL of blood is > 5% of total blood volume

Treatment and study plan

13C5-Calcium-L-Leucovorin

Drug

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 names: 13C5 Folate

Primary outcomes

  1. 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)

  2. Blood Folate - Study Period 2

    Time frame: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)

  3. Urine Folate - Study Period 1

    Time frame: 24h, 48h, 72h, 96h

  4. Urine Folate - Study Period 2

    Time frame: 24h, 48h, 72h

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of Florida

Registry information

Official study title

Folate Absorption Across the Large Intestine, Study #2: Capsule Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 17, 2009
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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