Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876732
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, Northwell Health

Tracking Information
First Submitted Date  ICMJE May 14, 2013
First Posted Date  ICMJE June 13, 2013
Results First Submitted Date  ICMJE February 6, 2014
Results First Posted Date  ICMJE September 8, 2014
Last Update Posted Date September 8, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
Change in Amount of Epogen Required [ Time Frame: Baseline and 4 months ]
The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Reduction in Epogen required [ Time Frame: 3 months ]
The effects of Vitamin B12 supplemenatation on erythropoitin alpha (Epogen) requirements in HD patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
Change in Quality of Life [ Time Frame: 3 month ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Improvement of quality of life [ Time Frame: 3 month ]
Subjects will be asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), both prior to therapy and after it is completed. Pre and post results will be compared.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Official Title  ICMJE Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Vitamin B12 Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Vitamin B12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
132
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01876732
Other Study ID Numbers  ICMJE 09-024
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzanne El-Sayegh, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Staten Island University Hospital
Investigators  ICMJE
Principal Investigator: Suzanne El-Sayegh, MD SIUH
PRS Account Northwell Health
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP