Trial | NCT00843453  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyanocobalamin ...

  • Study Participants

    36
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.
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 Started
Nov 30
2006
Primary Completion
Jan 31
2008
Study Completion
Apr 30
2008
Last Update
Jul 23
2009
Estimate

Other blood collection

blood collection

  • Other names: baseline

Drug treatment (cyanocobalamin nasal spray)

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

1 Other

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

2 Experimental

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

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
No Results Posted