HealthyFOLCANNCT00975351
Estimation of Plasma Folate Apparent Volume of Distribution in Adults
A study testing 13C5-labelled 5-methyltetrahydrofolic acid in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
The aim of this study is to calculate the plasma apparent volume of distribution of natural folate to give a more accurate value for use in a mathematical model of apparent folate absorption. 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-labelled 5-methyltetrahydrofolic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Dec 2010
- Phase
- Interventional
- 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
- Males and females
- Aged 18-65
- Body mass index above 19.5 and below 40
- Smokers and non-smokers
- Participation in the FolGene study
Who cannot join
- Pregnancy or been pregnant in last 12 months
- History of fits, seizures or blackouts
- Parallel participation in other research projects which invole dietary intervention and/or sampling of biological fluids/material which study nurses advice would affect either wellbeing of volunteer or the study data, apart from participation in the FolGene study
- Any person related to or living with a member of the study team
- Participation in another research project which involves blood sampling within the last 4 months unless total amount blood combined from both studies is less than 470ml
- Had donated blood within 16 weeks of starting the study
Show all 10Show fewer
- Prescribed medication for epilepsy/seizures
- Diabetics
- History of any gastrointestinal disorder requiring medical treatment
- Any long term medical condition requiring active treatment which may affect volunteers wellbeing or the study data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 6JF
About this study
The aim of this study is to calculate the plasma apparent volume of distribution of natural folate to give a more accurate value for use in a mathematical model of apparent folate absorption.
Read the detailed description
Bioavailability is a major determinant of nutritional status. In order to determine a safe level of folate fortification, its bioavailability must be assessed, so that risk-benefit analysis can be carried out. Recently, a mathematical model of folate true absorption which takes into account the liver first pass was devised (ref 1). In this model, the volume of distribution is a convenient method for describing how well a nutrient is removed from plasma and distributed into tissues.
In this study, volume of distribution will be more accurately estimated using an intravenous dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy adults aged 18-65, over a wide body mass index (BMI) range.
Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic acid, and blood samples will be taken at regular time points via a cannula over a 2hr time period.
The primary objective is to estimate the sampled plasma pool volume of distribution in order to quantify the fraction of any folate test dose, or folate metabolites, appearing in systemic plasma circulation in future studies of bioavailability.
- Conditions
- Healthy
- Being tested
- 13C5-labelled 5-methyltetrahydrofolic acid
- Keywords
- folates, 5-methyltetrahydrofolic acid, pharmacokinetics, bioavailability, biotransformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C5-labelled 5-methyltetrahydrofolic acidDietary supplement
Also called 13C5-labelled 5 methyltetrahydrofolic acid, calcium salt, 6S-5-CH3-H4-Pte[13C5] Glu-Ca
one intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals. Total 2hr "intervention".
| Study group | Role | What they receive |
|---|---|---|
| IV dose of 5-methyltetrahydrofolic acid | Experimental | IV test dose of 13C5-labelled 5-methyltetrahydrofolic acid to all eligible volunteers, followed by regular blood samplings over 2hr period taken via a cannula. Receives: Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of sampled plasma pool volume of distribution for natural folates
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2010
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Paul Finglas, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975351
- Sponsor's protocol ID
- IFR4/2008
- Other IDs
- 08/H0310/154
- Acronym
- FOLCAN
- Status last verified
- Feb 2013
- First submitted
- 10 Sep 2009
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright AJ, Finglas PM, Dainty JR, Wolfe CA, Hart DJ, Wright DM, Gregory JF. Differential kinetic behavior and distribution for pteroylglutamic acid and reduced folates: a revised hypothesis of the primary site of PteGlu metabolism in humans. J Nutr. 2005 Mar;135(3):619-23. doi: 10.1093/jn/135.3.619.
PubMed 15735104
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Plasma Folate Apparent Volume of Distribution in Adults
- ClinicalTrials.gov ID
- NCT00975351
- Acronym / sponsor ID
- FOLCAN / IFR4/2008
- Conditions
- Healthy
- Keywords
- folates, 5-methyltetrahydrofolic acid, pharmacokinetics, bioavailability, biotransformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Sep 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 aim of this study is to calculate the plasma apparent volume of distribution of natural folate to give a more accurate value for use in a mathematical model of apparent folate absorption.
Detailed description
Bioavailability is a major determinant of nutritional status. In order to determine a safe level of folate fortification, its bioavailability must be assessed, so that risk-benefit analysis can be carried out. Recently, a mathematical model of folate true absorption which takes into account the liver first pass was devised (ref 1). In this model, the volume of distribution is a convenient method for describing how well a nutrient is removed from plasma and distributed into tissues.
In this study, volume of distribution will be more accurately estimated using an intravenous dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy adults aged 18-65, over a wide body mass index (BMI) range.
Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic acid, and blood samples will be taken at regular time points via a cannula over a 2hr time period.
The primary objective is to estimate the sampled plasma pool volume of distribution in order to quantify the fraction of any folate test dose, or folate metabolites, appearing in systemic plasma circulation in future studies of bioavailability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV dose of 5-methyltetrahydrofolic acid | Experimental | Dietary Supplement: 13C5-labelled 5-methyltetrahydrofolic acidIV test dose of 13C5-labelled 5-methyltetrahydrofolic acid to all eligible volunteers, followed by regular blood samplings over 2hr period taken via a cannula. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females
- Aged 18-65
- Body mass index above 19.5 and below 40
- Smokers and non-smokers
- Participation in the FolGene study
Key exclusion criteria (10 listed)
- Pregnancy or been pregnant in last 12 months
- History of fits, seizures or blackouts
- Parallel participation in other research projects which invole dietary intervention and/or sampling of biological fluids/material which study nurses advice would affect either wellbeing of volunteer or the study data, apart from participation in the FolGene study
- Any person related to or living with a member of the study team
- Participation in another research project which involves blood sampling within the last 4 months unless total amount blood combined from both studies is less than 470ml
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-labelled 5-methyltetrahydrofolic acidAlso: 13C5-labelled 5 methyltetrahydrofolic acid, calcium salt, 6S-5-CH3-H4-Pte[13C5] Glu-Caone intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals. Total 2hr "intervention". | Dietary supplement | IV dose of 5-methyltetrahydrofolic acid |
Primary outcome
Estimation of sampled plasma pool volume of distribution for natural folates
Time frame: 2 hours
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 18 Feb 2013.
- Background: PubMed 15735104Wright AJ, Finglas PM, Dainty JR, Wolfe CA, Hart DJ, Wright DM, Gregory JF. Differential kinetic behavior and distribution for pteroylglutamic acid and reduced folates: a revised hypothesis of the primary site of PteGlu metabolism in humans. J Nutr. 2005 Mar;135(3):619-23. doi: 10.1093/jn/135.3.619.
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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.
Paul Finglas principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C5-labelled 5-methyltetrahydrofolic acid in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
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 5 inclusion and 10 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 18 Feb 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 United Kingdom. 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.
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?
Estimation of sampled plasma pool volume of distribution for natural folates (time frame: 2 hours). 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 NCT00975351, 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 18 Feb 2013.