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Trial record 4 of 88 for:    vitamin B12 deficiency

Metformin Use and Vitamin B12 Deficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136512
First Posted: June 3, 2010
Last Update Posted: July 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Northwell Health
  Purpose
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.

Condition
Vitamin B12 Deficiency Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Metformin Use and Vitamin B12 Deficiency

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Vitamin B12 level [ Time Frame: Single point ]

Secondary Outcome Measures:
  • methylmalonic acid [ Time Frame: single point ]

Enrollment: 89
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
metformin use
Patients with type 2 diabetes treated with metformin
no metformin use
Patients with type 2 diabetes who are not being treated with metformin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient and hospitalized patients with type 2 diabetes mellitus
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136512


Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Neil Cohen, M.D. Staten Island University Hospital
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01136512     History of Changes
Other Study ID Numbers: 07040
First Submitted: June 2, 2010
First Posted: June 3, 2010
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Northwell Health:
metformin
vitamin B12
type 2 diabetes
methylmalonic acid
deficiency

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Malnutrition
Nutrition Disorders
Metformin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypoglycemic Agents
Hematinics