Clinical trial NCT01876732: Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Official title: Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B12 Deficiency
Keywords: hemodialysis
viatmin B12 deficiency
Epogen
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2013-06-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Eligibility criteria: Inclusion Criteria:

* · Patients on Hemodialysis for at least 6 months

  * Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.

Exclusion Criteria:

* · On B12 treatment

  * Hematological Cancer
  * Methotrexate use
  * Alcohol use greater then 2 drinks per day
  * Vegetarian Diet
  * Gastric Surgery
  * Inflammatory Bowel Disease
  * Pernicious Anemia
  * Recent transfusion

Primary outcomes:
measure: Change in Amount of Epogen Required
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 3 month
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Island Rehab
state: New York
Study officials:
affiliation: SIUH
name: Suzanne El-Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References: