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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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00730574
Enrollment
100
Registered
2008-08-08
Start date
2008-07-31
Completion date
2012-01-31
Last updated
2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B12 Deficiency Combined With C677T Mutation on MTHFR Gene

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

Interventions

DIETARY_SUPPLEMENTVitamin B12 + Folic Acid

Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid

Sponsors

Moshe Flugelman
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026