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Completed

NCT Number: NCT01876732

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

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.

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Key information

Conditions

Vitamin B12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Island Rehab

Staten Island, New York, 10305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12

Drug

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 names: Cyanocobalamin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Staten Island University Hospital

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2013
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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