Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function

September 8, 2014 updated by: Moshe Flugelman

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. adult males and females of the broad population aged 20-60
  2. with no symptomatic heart disease/condition
  3. with Vitamin B12 levels of 150 pmol or less
  4. which have not received Vitamin B12 supplement treatment before

Exclusion Criteria:

  1. Adults suffering from a known heart disease/condition
  2. any disease the investigator might find as interfering with the process of the experiment
  3. tumor-oriented diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: B
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 .
Experimental: A
The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets)
Dietary supplement: Vitamin B12 + Folic Acid
Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid
Other Names:
  • Vitamin B12, 1 mg, by Solgar
  • Folic acid, 5 mg, by Rakah

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moshe Flugelman

Investigators

  • Principal Investigator: Moshe Y Flugelman, Carmel Medical Center, Haifa, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-07-0070-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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