Folate BioavailabilityNCT00130585
Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method
A study testing folic acid supplement and 13C11-labelled folic acid supplement in people with Folate Bioavailability and Healthy, run by Wageningen Centre for Food Sciences at 1 site in Netherlands.
Trial summary
The main objectives of this project are: 1. to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and 2. to determine the bioavailability with a higher precision than previous methods. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Folate Bioavailability, Healthy
- What is being tested?
- folic acid supplement and 13C11-labelled folic acid supplement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2005to Jun 2005
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum B12 >118pmol/L;
- Serum creatinine <125micromol/L;
- Plasma total homocysteine <26micromol/L.
Who cannot join
- Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
- Use of drugs interfering with folate metabolism;
- Use of B vitamins within the period three months prior to the study.
- Body Mass Index (BMI) > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method
The main objectives of this project are:
- to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
- to determine the bioavailability with a higher precision than previous methods.
The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.
Read the detailed description
Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.
- Conditions
- Folate Bioavailability, Healthy
- Being tested
- Controlled diet, folic acid supplement, 13C11-labelled folic acid supplement
- Keywords
- Folate, Bioavailability, Stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled dietBehavioural
folic acid supplementBehavioural
13C11-labelled folic acid supplementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability based on change in labelled folate concentration in plasma;
Bioavailability based on change in folate concentration in plasma
Secondary outcomes (1)
Bioavailability based on change in concentration in plasma homocysteine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folate BioavailabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Wageningen Centre for Food Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University
- Investigators
- Petra Verhoef, Dr., Principal investigator, Wageningen Centre for Food SciencesMartijn Katan, Professor, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130585
- Sponsor's protocol ID
- A-007-RW
- Status last verified
- Aug 2005
- First submitted
- 12 Aug 2005
- Last updated
- 4 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method
- ClinicalTrials.gov ID
- NCT00130585
- Acronym / sponsor ID
- A-007-RW
- Conditions
- Folate Bioavailability, Healthy
- Keywords
- Folate, Bioavailability, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Collaborators
- Wageningen University
- Study start
- May 2005
- Study completion
- Jun 2005
- First posted
- 15 Aug 2005 (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 main objectives of this project are:
- to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
- to determine the bioavailability with a higher precision than previous methods.
The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.
Detailed description
Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Serum B12 >118pmol/L;
- Serum creatinine <125micromol/L;
- Plasma total homocysteine <26micromol/L.
Key exclusion criteria (4 listed)
- Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
- Use of drugs interfering with folate metabolism;
- Use of B vitamins within the period three months prior to the study.
- Body Mass Index (BMI) > 30
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 |
|---|---|---|
| Controlled diet | Behavioural | – |
| folic acid supplement | Behavioural | – |
| 13C11-labelled folic acid supplement | Behavioural | – |
Primary outcome
Bioavailability based on change in labelled folate concentration in plasma;
Bioavailability based on change in folate concentration in plasma
1 secondary outcome
Bioavailability based on change in concentration in plasma homocysteine
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 4 Oct 2005.
Related trials for Folate Bioavailability
Not yet recruiting
PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
Folate, Folate Bioavailability
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.
Petra Verhoef, Dr. principal investigator
Wageningen Centre for Food Sciences
Martijn Katan, Professor principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid supplement and 13C11-labelled folic acid supplement in people with Folate Bioavailability and Healthy, run by Wageningen Centre for Food Sciences at 1 site in Netherlands.
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 3 inclusion and 4 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 4 Oct 2005. 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 Netherlands. 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?
Bioavailability based on change in labelled folate concentration in plasma;. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2005.