N/A
N=132
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Vitamin B12 Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01876732 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Amount of Epogen Required — -16,572 unit/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin B12 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Amount of Epogen Required |
-16,572 | — |
| SECONDARY Change in Quality of Life |
56.67; 67.50; 76.62; 75.69; 52.29; 54.58 | 0.047 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01876732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.