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NCT01136512 Clinical Trial

Metformin Use and Vitamin B12 Deficiency

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Metformin Use and Vitamin B12 Deficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01136512
Other study ID # 07040
Secondary ID
Status Completed
Phase N/A
First received June 2, 2010
Last updated July 29, 2013
Start date August 2007
Est. completion date December 2008

Study information
Verified date July 2013
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days

Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Staten Island University Hospital Staten Island New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin B12 level Single point Yes
Secondary methylmalonic acid single point No
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