B12 Deficiency Combined With C677T Mutation on MTHFR GeneNCT00730574
Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function
A study testing Vitamin B12 + Folic Acid in people with B12 Deficiency Combined With C677T Mutation on MTHFR Gene, run by Moshe Flugelman at 1 site in Israel.
Trial summary
The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- B12 Deficiency Combined With C677T Mutation on MTHFR Gene
- What is being tested?
- Vitamin B12 + Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jan 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult males and females of the broad population aged 20-60
- with no symptomatic heart disease/condition
- with Vitamin B12 levels of 150 pmol or less
- which have not received Vitamin B12 supplement treatment before
Who cannot join
- Adults suffering from a known heart disease/condition
- any disease the investigator might find as interfering with the process of the experiment
- tumor-oriented diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Commonness of the C677T Mutation in the MTHFR Gene in Subjects With B12 Deficiency and the Influence of the B12 Deficiency Combined With the C677T Mutation on the MTHFR Gene on Endothelial Function.
The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.
Read the detailed description
we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function
- Being tested
- Vitamin B12 + Folic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 + Folic AcidDietary supplement
Also called Vitamin B12, 1 mg, by Solgar, Folic acid, 5 mg, by Rakah
Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid
| Study group | Role | What they receive |
|---|---|---|
| B | No intervention | The control group, marked B, gets only B12 vitamin 1mg/day treatment to comply with ethics regulations seeing as they do suffer from B12 deficiency . |
| A | Experimental | The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets) Receives: Dietary Supplement: Vitamin B12 + Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure to determine the effect of the treatment will be reduced levels of Homocysteine in subjects with B12 deficiency combined with C677T mutation in the MTHFR gene.
Measured: The key measure would be measured upon enrollment and 6 weeks afterwards, upon completion of treatment based on 1mg Vitamin B12 sublinual and 5 mg Folic Acid per day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionJan 2012
Why it stopped: completed patient rectuitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B12 Deficiency Combined With C677T Mutation on MTHFR GeneStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moshe Flugelman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moshe Flugelman, Carmel Medical Center
- Investigators
- Moshe Y Flugelman, Principal investigator, Carmel Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730574
- Sponsor's protocol ID
- CMC-07-0070-CTIL
- Status last verified
- Sep 2014
- First submitted
- 7 Aug 2008
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Commonness of the C677T Mutation in the MTHFR Gene in Subjects With B12 Deficiency and the Influence of the B12 Deficiency Combined With the C677T Mutation on the MTHFR Gene on Endothelial Function.
- ClinicalTrials.gov ID
- NCT00730574
- Acronym / sponsor ID
- CMC-07-0070-CTIL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: completed patient rectuitment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Moshe FlugelmanUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Aug 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 purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.
Detailed description
we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | No intervention | –The control group, marked B, gets only B12 vitamin 1mg/day treatment to comply with ethics regulations seeing as they do suffer from B12 deficiency . |
| A | Experimental | Dietary Supplement: Vitamin B12 + Folic AcidThe trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult males and females of the broad population aged 20-60
- with no symptomatic heart disease/condition
- with Vitamin B12 levels of 150 pmol or less
- which have not received Vitamin B12 supplement treatment before
Key exclusion criteria (3 listed)
- Adults suffering from a known heart disease/condition
- any disease the investigator might find as interfering with the process of the experiment
- tumor-oriented diseases
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 |
|---|---|---|
| Vitamin B12 + Folic AcidAlso: Vitamin B12, 1 mg, by Solgar, Folic acid, 5 mg, by RakahTrial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid | Dietary supplement | A |
Primary outcome
The primary measure to determine the effect of the treatment will be reduced levels of Homocysteine in subjects with B12 deficiency combined with C677T mutation in the MTHFR gene.
Time frame: The key measure would be measured upon enrollment and 6 weeks afterwards, upon completion of treatment based on 1mg Vitamin B12 sublinual and 5 mg Folic Acid per day.
Results and safety
The study was stopped early (reason given: completed patient rectuitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
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.
Moshe Y Flugelman principal investigator
Carmel Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 + Folic Acid in people with B12 Deficiency Combined With C677T Mutation on MTHFR Gene, run by Moshe Flugelman at 1 site in Israel.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Sep 2014. 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 Israel. 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 was stopped early (reason given: completed patient rectuitment). Results are not available in the source record.
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?
The primary measure to determine the effect of the treatment will be reduced levels of Homocysteine in subjects with B12 deficiency combined with C677T mutation in the MTHFR gene. (time frame: The key measure would be measured upon enrollment and 6 weeks afterwards, upon completion of treatment based on 1mg Vitamin B12 sublinual and 5 mg Folic Acid per day.). 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 10 Sep 2014.