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| Name | Class |
|---|---|
| Staten Island University Hospital | OTHER |
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Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition called anemia. Some symptoms of anemia include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in maintaining a healthy nervous system. Nerves are surrounded by an insulating material that helps them conduct impulses. Patients with low B12 levels who receive this vitamin in injection form, state that there quality of life is better. Anemia in Hemodialysis patients is treated with Epogen, a synthetic material which helps your body make blood cells. The investigators believe that if you have a low vitamin B12 level in your blood and the investigators give you the vitamin during dialysis your requirement for epogen will be lower and you will be able to produce blood cells better. When evaluating for Vitamin B12 deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood test that will be performed and when this level is high and your vitamin B12 level is in the low normal range the investigators can make a diagnosis of vitamin B12 deficiency.
BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population.
METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency. Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months. Post-treatment MMA levels and smears were obtained. Erythropoietin dosages were monitored throughout the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B12 | Experimental | Those with an MMA over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B12 | Drug | Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Amount of Epogen Required | The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score. |
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Inclusion Criteria:
· Patients on Hemodialysis for at least 6 months
Exclusion Criteria:
· On B12 treatment
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne El-Sayegh, MD | SIUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Island Rehab | Staten Island | New York | 10305 | United States |
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Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin B12 | Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin B12 | Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | From a single center dialysis unit, patients 18-80 on hemodialysis at least 6 months and taking Epogen were screened for serum Vitamin B12 levels and plasma MMA. Those with an MMA level greater than 800mmol/L had smears of their peripheral blood examined to assess for characteristic findings that are consistent with vitamin B12 deficiency. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Amount of Epogen Required | The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients | Posted | Mean | Standard Deviation | unit/ml | Baseline and 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin B12 | Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment. |
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There were too few patients with MMA levels over 800 to determine sensitivity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne El-Sayegh | Staten Island University Hospital | 718-226-6158 | uviola@siuh.edu |
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| 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 |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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|
|
| 3 month |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Quality of Life | The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score. | Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared. | Posted | Mean | Standard Deviation | Scores on a Scale | 3 month |
|
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| 0 |
| 57 |
| 0 |
| 57 |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Symptom/problem list (post-test) |
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| Effects of kidney disease (pre-test) |
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| Effects of kidney disease (post-test) |
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| Burden of kidney disease pre-test |
|
| Burden of kidney disease (post-test) |
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| Work status (pre-test) |
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| Work status (post-test) |
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| Cognitive function (pre-test) |
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| Cognitive function (post-test) |
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| Quality of social interaction (pre-test) |
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| Quality of social interaction (post-test) |
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| Sexual function (pre-test) |
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| Sexual function (post-test) |
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| Sleep (pre-test) |
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| Sleep (post-test) |
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| Social support (pre-test) |
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| Social support (post-test) |
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| Dialysis staff encouragement (pre-test) |
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| Dialysis staff encouragement (post-test) |
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| Overall health (pre-test) |
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| Overall health (post-test) |
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| Patient satisfaction (pre-test) |
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| Patient satisfaction (post-test) |
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| Physical functioning (pre-test) |
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| Physical functioning (post-test) |
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| Role-physical (pre-test) |
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| Role-physical (post-test) |
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| Pain (pre-test) |
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| Pain (post-test) |
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| General health (pre-test) |
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| General health (post-test) |
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| Emotional well-being (pre-test) |
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| Emotional well-being (post-test) |
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| Role-emotional (pre-test) |
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| Role-emotional (post-test) |
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| Energy/fatigue (pre-test) |
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| Energy/fatigue (post-test) |
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| SF-12 physical composite (pre-test) |
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| SF-12 physical composite (post-test) |
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| SF-12 mental composite (pre-test) |
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| SF-12 mental composite (post-test) |
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| Social function (pre to post change) |
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| Symptom/problem list (pre to post change) |
|
| Effects of kidney disease (pre to post change) |
|
| Burden of kidney disease (pre to post change) |
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| Work status (pre to post change) |
|
| Cognitive function (pre to post change) |
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| Quality of social interaction (pre to post change) |
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| Sleep (pre to post change) |
|
| Social support (pre to post change) |
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| Dialysis staff encouragement (pre to post change) |
|
| Overall health (pre to post change) |
|
| Patient satisfaction (pre to post change) |
|
| Physical functioning (pre to post change) |
|
| Role-physical (pre to post change) |
|
| Pain (pre to post change) |
|
| General health (pre to post change) |
|
| Emotional well-being (pre to post change) |
|
| Role-emotional (pre to post change) |
|
| Energy/fatigue (pre to post change) |
|
| SF-12 physical composite (pre to post change) |
|
| SF-12 mental composite (pre to post change) |
|
P- value of " symptom/problem list " |
| No |
| Superiority or Other |
| Wilcoxon signed-rank test | 0.772 | P- value of " effects of kidney disease " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.301 | P-value of " burden of kidney disease " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.250 | P-value of " work status " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.895 | P-value of " cognitive function " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.281 | P-value of " quality of social interaction " | No | Superiority or Other |
| Wilcoxon signed-rank test | 1.00 | P-value of " sleep " | No | Superiority or Other |
| Wilcoxon signed-rank test | 1.00 | P-value of " social support " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.943 | P-value of " dialysis staff encouragement " | No | Superiority or Other |
| Wilcoxon signed-rank test | 1.00 | P-value of " overall health " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.090 | P-value of " patient satisfaction " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.391 | P-value of " physical functioning " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.438 | P-value of " role-physical " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.424 | P-value of " pain " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.169 | P-value of " general health " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.858 | P-value of " emotional well-being " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.156 | P-value of " role-emotional " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.084 | P-value of " energy/fatigue " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.583 | P-value of " SF-12 physical composite " | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.358 | p-value of " SF-12 mental composite " | No | Superiority or Other |