Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01876732
First received: May 14, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Vitamin B12 Deficiency
Drug: Vitamin B12

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Change in Amount of Epogen Required [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients


Secondary Outcome Measures:
  • Change in Quality of Life [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 132
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin B12
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.
Drug: 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 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 Name: Cyanocobalamin

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876732

Locations
United States, New York
Island Rehab
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Suzanne El-Sayegh, MD SIUH
  More Information

No publications provided

Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01876732     History of Changes
Obsolete Identifiers: NCT01360983
Other Study ID Numbers: 09-024
Study First Received: May 14, 2013
Results First Received: February 6, 2014
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
hemodialysis
viatmin B12 deficiency
Epogen

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Avitaminosis
Malnutrition
Nutrition Disorders
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014