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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Carmel Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00730574
First received: August 7, 2008
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  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: B12 Vitamin
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:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

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 ]

Estimated Enrollment: 300
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (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 but they do not get the combined B12 + Folic acid treatment as do the trial subjects
 Dietary Supplement: B12 Vitamin
Control group would only receive daily treatment of 1mg Vitamin B12 sublingual seeing as they suffer from Vitamin B12 deficiency
Other Name: Vitamin B12, 1 mg, by Solgar - sublingual tablets
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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730574

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

No publications provided

Responsible Party: Prof. Moshe Flugelman, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00730574     History of Changes
Other Study ID Numbers: CMC-0070-07
Study First Received: August 7, 2008
Last Updated: January 11, 2010
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013