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Sponsored by: |
Carmel Medical Center |
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Information provided by: | Carmel Medical Center |
ClinicalTrials.gov Identifier: | NCT00730574 |
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 |
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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. |
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 |
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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
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Dietary Supplement: B12 Vitamin
Control group would only receive daily treatment of 1mg Vitamin B12 sublingual seeing as they suffer from Vitamin B12 deficiency
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A: Experimental
The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5Mg Folic acid (tablets)
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Dietary Supplement: Vitamin B12 + Folic Acid
Trial group would get daily treatment of 1mg Vitamin B12 combined with 5mg Folic Acid
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Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Moshe Y Flugelman, Prof. | +972-4-8250575 | flugelman_m@clalit.org.il |
Israel | |
Carmel Medical Center | Recruiting |
Haifa, Israel, 34362 | |
Principal Investigator: Moshe Y Flugelman, Prof. |
Principal Investigator: | Moshe Y Flugelman | Carmel Medical Center, Haifa, Israel |
Responsible Party: | Carmel Medical Center ( Prof. Moshe Flugelman ) |
Study ID Numbers: | CMC-0070-07 |
Study First Received: | August 7, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00730574 |
Health Authority: | Israel: Ethics Commission |
Folic Acid Hydroxocobalamin Vitamin B 12 |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |