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Metformin Use and Vitamin B12 Deficiency

This study has been completed.
Information provided by (Responsible Party):
Northwell Health Identifier:
First received: June 2, 2010
Last updated: July 29, 2013
Last verified: July 2013
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.

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)
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


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

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

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Please refer to this study by its identifier: NCT01136512

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

Responsible Party: Northwell Health Identifier: NCT01136512     History of Changes
Other Study ID Numbers: 07040
Study First Received: June 2, 2010
Last Updated: July 29, 2013

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin B 12 Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin B Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypoglycemic Agents
Hematinics processed this record on September 21, 2017