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

NCT ID: NCT00843453

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-04-30

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.

Conditions

Vitamin B12 Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: OTHER

blood collection

Intervention Type: OTHER

blood collection

2

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

Group Type: EXPERIMENTAL

treatment (cyanocobalamin nasal spray)

Intervention Type: DRUG

cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

Interventions

blood collection

blood collection

Intervention Type: OTHER

treatment (cyanocobalamin nasal spray)

cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

Intervention Type: DRUG

Other Intervention Names

baseline

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

University of Delaware

Principal Investigators

Nancy R Rozgony, RD< LD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Chengshun R Fang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

Long View Nursing Home

Manchester, Maryland, United States

Stella Maris Nursing Home

Timonium, Maryland, United States

Countries

United States

Other Identifiers

HS08-165

Identifier Type: -

Identifier Source: org_study_id