HealthyPhase 1NCT00941174
Folate Absorption Across the Large Intestine
A Phase 1 study testing 13C5-Calcium-L-Leucovorin in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 13C5-Calcium-L-Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Age 18-65 years
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Folate Absorption Across the Large Intestine, Study #2: Capsule Study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- 13C5-Calcium-L-Leucovorin
- Keywords
- (13C5) Calcium Leucovorin, Folate absorption across the large intestine, Folate Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C5-Calcium-L-LeucovorinDrug
Also called 13C5 Folate
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.
| Study group | Role | What they receive |
|---|---|---|
| Capsule: 400 microg 13C5-Calcium-L-Leucovorin | Active comparator | Not described Receives: Drug: 13C5-Calcium-L-Leucovorin |
| IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin | Active comparator | Not described Receives: Drug: 13C5-Calcium-L-Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Folate - Study Period 1
Measured: 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
Measured: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)
Urine Folate - Study Period 1
Measured: 24h, 48h, 72h, 96h
Urine Folate - Study Period 2
Measured: 24h, 48h, 72h
Secondary outcomes (1)
Dietary Recall Records for folate analysis during urine collection days, Anthropometric.
Measured: Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Florida
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah O'Connor, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941174
- Sponsor's protocol ID
- 1000008487-2b
- Status last verified
- Dec 2013
- First submitted
- 14 Jul 2009
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25332326
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folate Absorption Across the Large Intestine, Study #2: Capsule Study
- ClinicalTrials.gov ID
- NCT00941174
- Acronym / sponsor ID
- 1000008487-2b
- Conditions
- Healthy
- Keywords
- (13C5) Calcium Leucovorin, Folate absorption across the large intestine, Folate Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Florida
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- Age 18-65 years
Key exclusion criteria (7 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C5-Calcium-L-LeucovorinAlso: 13C5 FolateThis 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. | Drug | Capsule: 400 microg 13C5-Calcium-L-Leucovorin, IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Derived from this study: PubMed 25332326Lakoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah O'Connor, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 13C5-Calcium-L-Leucovorin in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013; AzTrials last refreshed its copy on 31 Oct 2026.