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Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

This study has been completed.
Sponsor:
Information provided by:
University of Delaware
ClinicalTrials.gov Identifier:
NCT00843453
First received: February 12, 2009
Last updated: July 21, 2009
Last verified: July 2009
History of Changes
  Purpose

This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.


Condition Intervention
Vitamin B12 Deficiency
 Other: blood collection
Drug: treatment (cyanocobalamin nasal spray)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • serum vitamin B12 [ Time Frame: baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
  • serum methylmalonic acid (MMA) [ Time Frame: at baseline and after eight weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups
 Other: blood collection
blood collection
Other Name: baseline
Experimental: 2
Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.
 Drug: treatment (cyanocobalamin nasal spray)
cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

Detailed Description:

Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.

  Eligibility

Ages Eligible for Study:   60 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 60-89 years
  • PPI use for >12 months (PPI group)
  • no PPI use for 30 days prior to arm 1
  • long term care resident

Exclusion Criteria:

  • pernicious anemia
  • severe megaloblastic anemia
  • free-living
  • serum creatinine > 1.8 mg/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843453

Locations
United States, Maryland
Long View Nursing Home
Manchester, Maryland, United States, 21102
Stella Maris Nursing Home
Timonium, Maryland, United States, 21093
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Nancy R Rozgony, RD< LD University of Delaware
Principal Investigator: Chengshun R Fang, Ph.D. University of Delaware
  More Information

No publications provided

Responsible Party: Nancy R. Rozgony, MS, RD,LD, University of Delaware
ClinicalTrials.gov Identifier: NCT00843453     History of Changes
Other Study ID Numbers: HS08-165
Study First Received: February 12, 2009
Last Updated: July 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Delaware:
vitamin B12 deficiency
cyanocobalamin deficiency
proton pump inhibitors
omeprazole

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Avitaminosis
Malnutrition
Nutrition Disorders
 Proton Pump Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013