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

This study has been terminated.
(completed patient rectuitment)
Sponsor:
Information provided by (Responsible Party):
Moshe Flugelman, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00730574
First received: August 7, 2008
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
B12 Deficiency Combined With C677T Mutation on MTHFR Gene
Dietary Supplement: Vitamin B12 + Folic Acid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 7, 2008
Last Updated: September 8, 2014
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014