CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
Vitamin B12drug
Likely dose
Vitamin B12 1000mcgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01876732
NCT01876732N/ACompleted

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

Northwell Health·interventional·Posted Jun 13, 2013·Updated Sep 8, 2014

In Brief

A clinical study evaluating Vitamin B12 for Vitamin B12 Deficiency. Completed, enrolled 132 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2013
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.1 years ago

Interventions

Vitamin B12drug

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.