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

Not Applicable

Completed

• Conditions: Vitamin B12 Deficiency
• Interventions: Other: blood collection; Drug: treatment (cyanocobalamin nasal spray)

• Registration Number: NCT00843453
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-11
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-21
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	blood collection	Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups
2	treatment (cyanocobalamin nasal spray)	Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.

Primary Outcome Measures

Name	Time	Method
serum vitamin B12	baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)	at baseline and after eight weeks of treatment

Trial Locations

Locations (2)

Long View Nursing Home; 🇺🇸 Manchester, Maryland, United States

Stella Maris Nursing Home; 🇺🇸 Timonium, Maryland, United States