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Completed

NCT Number: NCT00843453

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

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.

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Key information

Conditions

Vitamin B12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long View Nursing Home, Manchester, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

blood collection

Other names: baseline

treatment (cyanocobalamin nasal spray)

Drug

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

Primary outcomes

  1. serum vitamin B12

    Time frame: baseline and after 8 weeks of treatment

  2. serum methylmalonic acid (MMA)

    Time frame: at baseline and after eight weeks of treatment

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2009
Registry last updated
Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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