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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00843453
Enrollment
36
Registered
2009-02-13
Start date
2006-11-30
Completion date
2008-04-30
Last updated
2009-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin B12 Deficiency

Keywords

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

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.

Interventions

OTHERblood collection

blood collection

DRUGtreatment (cyanocobalamin nasal spray)

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

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum vitamin B12baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)at baseline and after eight weeks of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026