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

Not Applicable

Terminated

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

• Registration Number: NCT00730574
• Lead Sponsor: Moshe Flugelman

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2011-03
• Study Completion: 2012-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Vitamin B12 + Folic Acid	The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel