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

NCT ID: NCT00730574

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-01-31

Brief Summary

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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

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we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function

Conditions

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B12 Deficiency Combined With C677T Mutation on MTHFR Gene

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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 .

Group Type NO_INTERVENTION

No interventions assigned to this group

A

The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets)

Group Type EXPERIMENTAL

Vitamin B12 + Folic Acid

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin B12 + Folic Acid

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin B12, 1 mg, by Solgar Folic acid, 5 mg, by Rakah

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moshe Flugelman

OTHER

Sponsor Role lead

Responsible Party

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Moshe Flugelman

Principal Investigator and Sponsor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Moshe Y Flugelman

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center, Haifa, Israel

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CMC-07-0070-CTIL

Identifier Type: -

Identifier Source: org_study_id

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