We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00843453
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : July 23, 2009
Information provided by:
University of Delaware

Brief Summary:
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 or disease Intervention/treatment
Vitamin B12 Deficiency Other: blood collection Drug: treatment (cyanocobalamin nasal spray)

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Study Start Date : November 2006
Primary Completion Date : January 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. serum vitamin B12 [ Time Frame: baseline and after 8 weeks of treatment ]
  2. serum methylmalonic acid (MMA) [ Time Frame: at baseline and after eight weeks of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00843453

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
Principal Investigator: Nancy R Rozgony, RD< LD University of Delaware
Principal Investigator: Chengshun R Fang, Ph.D. University of Delaware

Responsible Party: Nancy R. Rozgony, MS, RD,LD, University of Delaware
ClinicalTrials.gov Identifier: NCT00843453     History of Changes
Other Study ID Numbers: HS08-165
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Vitamin B Complex
Nutrition Disorders
Proton Pump Inhibitors
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action