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

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: B12 Deficiency Combined With C677T Mutation on MTHFR Gene
• Intervention / Treatment: Dietary supplement: Vitamin B12 + Folic Acid

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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

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

Study record dates

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: Physiological Effects of Drugs; Micronutrients; Hematinics; Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin; Vitamin B Complex
• Other Study ID Numbers: CMC-07-0070-CTIL