Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Information source: University of Delaware
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B12 Deficiency
Intervention: blood collection (Other); treatment (cyanocobalamin nasal spray) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Delaware Official(s) and/or principal investigator(s): Nancy R Rozgony, RD< LD, Principal Investigator, Affiliation: University of Delaware Chengshun R Fang, Ph.D., Principal Investigator, Affiliation: University of Delaware
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.
Clinical Details
Official title: Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: serum vitamin B12serum methylmalonic acid (MMA)
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
Minimum age: 60 Years.
Maximum age: 89 Years.
Gender(s): Both.
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
Locations and Contacts
Long View Nursing Home, Manchester, Maryland 21102, United States
Stella Maris Nursing Home, Timonium, Maryland 21093, United States
Additional Information
Starting date: November 2006
Last updated: July 21, 2009
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