Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Condition: Vitamin B12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Vitamin B12
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Cyanocobalamin
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: hemodialysis; viatmin B12 deficiency; Epogen