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

July 21, 2009 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Manchester, Maryland, United States, 21102
        • Long View Nursing Home
      • Timonium, Maryland, United States, 21093
        • Stella Maris Nursing Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups
Other: blood collection
blood collection
Other Names:
  • baseline
EXPERIMENTAL: 2
Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.
Drug: treatment (cyanocobalamin nasal spray)
cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum vitamin B12
Time Frame: baseline and after 8 weeks of treatment
baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)
Time Frame: at baseline and after eight weeks of treatment
at baseline and after eight weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Investigators

  • Principal Investigator: Nancy R Rozgony, RD< LD, University of Delaware
  • Principal Investigator: Chengshun R Fang, Ph.D., University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (ESTIMATE)

February 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 21, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS08-165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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