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

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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

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.

Condition or disease Intervention/treatment Phase
B12 Deficiency Combined With C677T Mutation on MTHFR Gene Dietary Supplement: Vitamin B12 + Folic Acid Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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.
Study Start Date : July 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : January 2012


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




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730574


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Moshe Flugelman
Investigators
Principal Investigator: Moshe Y Flugelman Carmel Medical Center, Haifa, Israel

Responsible Party: Moshe Flugelman, Principal Investigator and Sponsor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00730574     History of Changes
Other Study ID Numbers: CMC-07-0070-CTIL
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Vitamins
Folic Acid
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics