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

B12 Deficiency Combined With C677T Mutation on MTHFR Gene Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00730574
• Other study ID #: CMC-07-0070-CTIL
• Status: Terminated
• Phase: N/A
• First received: August 7, 2008
• Last updated: September 8, 2014
• Start date: July 2008
• Est. completion date: January 2012

Study information

• Verified date: September 2014
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• B12 Deficiency Combined With C677T Mutation on MTHFR Gene

Intervention

Dietary Supplement:
• Vitamin B12 + Folic Acid
Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Moshe Flugelman

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No