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

University of Delaware

Status: Completed

Conditions: Vitamin B12 Deficiency

Treatments: Other: blood collection; Drug: treatment (cyanocobalamin nasal spray)

Study type: Interventional

Funder types: Other

Identifiers

NCT00843453

HS08-165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Other group

Description:

Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups

Treatment:

Other: blood collection

2

Experimental group

Description:

Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.

Treatment:

Drug: treatment (cyanocobalamin nasal spray)