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Trial record 2 of 88 for:    vitamin B12 deficiency

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

This study has been completed.
Information provided by:
University of Delaware Identifier:
First received: February 12, 2009
Last updated: July 21, 2009
Last verified: July 2009
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: None (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:

Further study details as provided by University of Delaware:

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

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
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.

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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Nancy R. Rozgony, MS, RD,LD, University of Delaware Identifier: NCT00843453     History of Changes
Other Study ID Numbers: HS08-165
Study First Received: February 12, 2009
Last Updated: July 21, 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
Hematinics processed this record on September 20, 2017