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

NCT01876732 | Completed Results DMC

• 1 other identifier: 09-024
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin B12 Deficiency

Keywords

hemodialysis; viatmin B12 deficiency; Epogen

Outcome Measures

Primary Outcomes (1)

• Change in Amount of Epogen Required

  The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients

  Baseline and 4 months

Secondary Outcomes (1)

• Change in Quality of Life

  3 month

Study Arms (1)

Vitamin B12

EXPERIMENTAL

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

Interventions

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.

Also known as: Cyanocobalamin

Vitamin B12

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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.

You may not qualify if:

• · 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

Sponsors & Collaborators

• Northwell Health: lead
• Staten Island University Hospital: collaborator

Study Sites (1)

Island Rehab

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

There were too few patients with MMA levels over 800 to determine sensitivity.

Results Point of Contact

• Title: Suzanne El-Sayegh
• Organization: Staten Island University Hospital

uviola@siuh.edu

718-226-6158

Study Officials

• Suzanne El-Sayegh, MD

  SIUH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Attending, Assoc. Chair of Medicine

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 8, 2014
• Results First Posted: September 8, 2014

Record last verified: 2014-09

Locations

US (1)