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

Vitamin B12 Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876732
• Other study ID #: 09-024
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: September 5, 2014
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01360983

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Island Rehab	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Amount of Epogen Required	The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients	Baseline and 4 months	Yes
Secondary	Change in Quality of Life	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.	3 month	No