Folate Absorption Across the Large Intestine

NCT00941174 | Completed Phase 1

• 1 other identifier: 1000008487-2b
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

(13C5) Calcium Leucovorin; Folate absorption across the large intestine; Folate Bioavailability

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Capsule: 400 microg 13C5-Calcium-L-Leucovorin

ACTIVE COMPARATOR

Drug: 13C5-Calcium-L-Leucovorin

IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin

ACTIVE COMPARATOR

Drug: 13C5-Calcium-L-Leucovorin

Interventions

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.

Also known as: 13C5 Folate

Capsule: 400 microg 13C5-Calcium-L-Leucovorin; IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Age 18-65 years

You may not qualify if:

• \<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
• mL of blood is \> 5% of total blood volume

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Centers for Disease Control and Prevention: collaborator
• University of Florida: collaborator

Study Sites (1)

The Hospital For Sick Chidlren

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 25332326 DERIVED

Study Officials

• Deborah O'Connor, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief, Clinical Dietetics

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 17, 2009
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

CA (1)