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

Sponsor:	Carmel Medical Center
Information provided by:	Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT00730574

Purpose

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.

Condition	Intervention
B12 Deficiency Combined With C677T Mutation on MTHFR Gene	Dietary Supplement: B12 Vitamin Dietary Supplement: Vitamin B12 + Folic Acid

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: No Intervention 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 but they do not get the combined B12 + Folic acid treatment as do the trial subjects	Dietary Supplement: B12 Vitamin Control group would only receive daily treatment of 1mg Vitamin B12 sublingual seeing as they suffer from Vitamin B12 deficiency
A: Experimental 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

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult males and females of the broad population aged 20-60
with no symptomatic heart disease/condition
with Vitamin B12 levels of 150 pmol or less
which have not received Vitamin B12 supplement treatment before

Exclusion Criteria:

Adults suffering from a known heart disease/condition
any disease the investigator might find as interfering with the process of the experiment
tumor-oriented diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730574

Contacts

Contact: Moshe Y Flugelman, Prof.

+972-4-8250575

flugelman_m@clalit.org.il

Locations

Israel
Carmel Medical Center	Recruiting
Haifa, Israel, 34362
Principal Investigator: Moshe Y Flugelman, Prof.

Sponsors and Collaborators

Carmel Medical Center

Investigators

Principal Investigator:

Moshe Y Flugelman

Carmel Medical Center, Haifa, Israel

More Information

No publications provided

Responsible Party:	Carmel Medical Center ( Prof. Moshe Flugelman )
Study ID Numbers:	CMC-0070-07
Study First Received:	August 7, 2008
Last Updated:	November 8, 2009
ClinicalTrials.gov Identifier:	NCT00730574 History of Changes
Health Authority:	Israel: Ethics Commission

Additional relevant MeSH terms:

Folic Acid
Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Hydroxocobalamin
Vitamin B 12
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009