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

Primary Purpose

Vitamin B12 Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

blood collection

treatment (cyanocobalamin nasal spray)

About this trial

This is an interventional prevention trial for Vitamin B12 Deficiency focused on measuring vitamin B12 deficiency, cyanocobalamin deficiency, proton pump inhibitors, omeprazole

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Long View Nursing Home
Stella Maris Nursing Home

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum vitamin B12

serum methylmalonic acid (MMA)

Secondary Outcome Measures

Full Information

NCT ID

NCT00843453

First Posted

February 12, 2009

Last Updated

July 21, 2009

Sponsor

University of Delaware

1. Study Identification

Unique Protocol Identification Number

NCT00843453

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Delaware

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin B12 Deficiency

Keywords

vitamin B12 deficiency, cyanocobalamin deficiency, proton pump inhibitors, omeprazole

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

blood collection

Other Intervention Name(s)

baseline

Intervention Description

blood collection

Intervention Type

Drug

Intervention Name(s)

treatment (cyanocobalamin nasal spray)

Intervention Description

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

Primary Outcome Measure Information:

Title

serum vitamin B12

Time Frame

baseline and after 8 weeks of treatment

Title

serum methylmalonic acid (MMA)

Time Frame

at baseline and after eight weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy R Rozgony, RD< LD

Organizational Affiliation

University of Delaware

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chengshun R Fang, Ph.D.

Organizational Affiliation

University of Delaware

Official's Role

Principal Investigator

Facility Information:

Facility Name

Long View Nursing Home

City

Manchester

State/Province

Maryland

ZIP/Postal Code

21102

Country

United States

Facility Name

Stella Maris Nursing Home

City

Timonium

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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