Trial record 4 of 82 for:    vitamin B12 deficiency

Metformin Use and Vitamin B12 Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01136512
First received: June 2, 2010
Last updated: July 29, 2013
Last verified: July 2013
  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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Vitamin B12 level [ Time Frame: Single point ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • methylmalonic acid [ Time Frame: single point ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136512

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

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01136512     History of Changes
Other Study ID Numbers: 07040
Study First Received: June 2, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
metformin
vitamin B12
type 2 diabetes
methylmalonic acid
deficiency

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
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
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 23, 2014