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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00730574
Recruitment Status : Terminated (completed patient rectuitment)
First Posted : August 8, 2008
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Moshe Flugelman, Carmel Medical Center

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE August 8, 2008
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE July 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function
Official Title  ICMJE 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.
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE B12 Deficiency Combined With C677T Mutation on MTHFR Gene
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)
    Intervention: Dietary Supplement: Vitamin B12 + Folic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2008)
300
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00730574
Other Study ID Numbers  ICMJE CMC-07-0070-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moshe Flugelman, Carmel Medical Center
Study Sponsor  ICMJE Moshe Flugelman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moshe Y Flugelman Carmel Medical Center, Haifa, Israel
PRS Account Carmel Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP