HealthyNCT00689949
Validation of Urinary Biomarkers of Folate Status
A study testing folic acid in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The major objective of the proposed study is to demonstrate the suitability of new markers for folate status in humans, which avoid blood sampling, as required for the established marker RBC folate concentration, but can be obtained from spot urine samples. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Dec 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18 - 45 years
- apparently healthy
- normal results on haematologic pattern and blood chemistry tests (according to university hospital reference values)
- plasma vitamin B12 > 160 pmol/l
- no diagnosis of intestinal, renal or thyroid disease (self reported)
- only male subjects will be enrolled but regular consumption of vitamin supplements (including folate) is not an exclusion criterium, as we aim to cover a wide range of folate concentrations.
Who cannot join
- recent (3 months) treatment with medication, assumed to interfere with folate status
- abuse of alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status
The major objective of the proposed study is to demonstrate the suitability of new markers for folate status in humans, which avoid blood sampling, as required for the established marker RBC folate concentration, but can be obtained from spot urine samples. For this reason urine and blood will be collected from volunteers, twice at baseline and in a subgroup after 6 and 12 weeks of intake of a folic acid supplement
Specific hypotheses to be tested:
Read more
Correlation study:
- The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine concentration from the total p-ABG concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
- The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine concentration form the FIGLU concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
Intervention study:
Changes in folate status (RBC folate) after supplementary intake of folate result in increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate status and in subjects identified with a high folate status among the study participants of the correlation study
- Conditions
- Healthy
- Being tested
- folic acid
- Keywords
- folic acid, folate, p-aminobenzoylglutamate, formiminoglutamate, homocysteine, experimental validation of a new biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDietary supplement
0.4 mg of folic acid per day
| Study group | Role | What they receive |
|---|---|---|
| folic acid | Other | Not described Receives: Dietary Supplement: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Measured: study day 1
Secondary outcomes (2)
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Measured: study day 42
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Measured: study day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Investigators
- Berthold Koletzko, Prof. Dr., Principal investigator, Haunersche Kinderklinik, Ludwig-Maximilians-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689949
- Sponsor's protocol ID
- 144-08
- Status last verified
- Dec 2012
- First submitted
- 30 May 2008
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status
- ClinicalTrials.gov ID
- NCT00689949
- Acronym / sponsor ID
- 144-08
- Conditions
- Healthy
- Keywords
- folic acid, folate, p-aminobenzoylglutamate, formiminoglutamate, homocysteine, experimental validation of a new biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jun 2008 (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 major objective of the proposed study is to demonstrate the suitability of new markers for folate status in humans, which avoid blood sampling, as required for the established marker RBC folate concentration, but can be obtained from spot urine samples. For this reason urine and blood will be collected from volunteers, twice at baseline and in a subgroup after 6 and 12 weeks of intake of a folic acid supplement
Specific hypotheses to be tested:
Correlation study:
- The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine concentration from the total p-ABG concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
- The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine concentration form the FIGLU concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
Intervention study:
Changes in folate status (RBC folate) after supplementary intake of folate result in increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate status and in subjects identified with a high folate status among the study participants of the correlation study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| folic acid | Other | Dietary Supplement: folic acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age: 18 - 45 years
- apparently healthy
- normal results on haematologic pattern and blood chemistry tests (according to university hospital reference values)
- plasma vitamin B12 > 160 pmol/l
- no diagnosis of intestinal, renal or thyroid disease (self reported)
Key exclusion criteria (2 listed)
- recent (3 months) treatment with medication, assumed to interfere with folate status
- abuse of alcohol or drugs
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 |
|---|---|---|
| folic acid0.4 mg of folic acid per day | Dietary supplement | folic acid |
Primary outcome
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time frame: study day 1
2 secondary outcomes
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time frame: study day 42
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time frame: study day 84
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 24 Dec 2012.
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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.
Berthold Koletzko, Prof. Dr. principal investigator
Haunersche Kinderklinik, Ludwig-Maximilians-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 in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 6 inclusion and 2 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 24 Dec 2012. 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 Germany. 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?
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate (time frame: study day 1). 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 24 Dec 2012.