Vitamin B12 Deficiency Clinical Trial
Official title:
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
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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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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