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

Vitamin B12 Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843453
• Other study ID #: HS08-165
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: July 21, 2009
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2009
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 89 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

Other:
• blood collection
blood collection

Drug:
• treatment (cyanocobalamin nasal spray)
cyanocobalamin nasal spray -- 500 mcg q week for eight weeks

Locations

Country	Name	City	State
United States	Long View Nursing Home	Manchester	Maryland
United States	Stella Maris Nursing Home	Timonium	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum vitamin B12		baseline and after 8 weeks of treatment	No
Primary	serum methylmalonic acid (MMA)		at baseline and after eight weeks of treatment	No