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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood collection | Other | blood collection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| serum vitamin B12 | baseline and after 8 weeks of treatment | |
| serum methylmalonic acid (MMA) | at baseline and after eight weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy R Rozgony, RD< LD | University of Delaware | Principal Investigator |
| Chengshun R Fang, Ph.D. | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long View Nursing Home | Manchester | Maryland | 21102 | United States | ||
| Stella Maris Nursing Home |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2018 | |
| Reset | Mar 8, 2018 | |
| Release | Oct 10, 2018 | |
| Reset | Nov 7, 2018 | |
| Release | Aug 11, 2020 | |
| Reset | Aug 18, 2020 | |
| Release | Oct 8, 2021 | |
| Reset | Nov 3, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2018 | Mar 8, 2018 | |||
| Oct 10, 2018 |
| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| C074807 | BaseLine dental cement |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| treatment (cyanocobalamin nasal spray) |
| Drug |
cyanocobalamin nasal spray -- 500 mcg q week for eight weeks |
|
| Timonium |
| Maryland |
| 21093 |
| United States |
| Nov 7, 2018 |
| Aug 11, 2020 | Aug 18, 2020 |
| Oct 8, 2021 | Nov 3, 2021 |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |