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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


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 B12

serum 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.


Minimum age: 60 Years. Maximum age: 89 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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