Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
|ClinicalTrials.gov Identifier: NCT01876732|
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vitamin B12 Deficiency||Drug: Vitamin B12||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876732
|United States, New York|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Suzanne El-Sayegh, MD||SIUH|