Trial record 13 of 69 for: vitamin B12 deficiency

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Impact of Vitamin b12 Replacement on Epogen Requirements in Hemodialysis Patients and Impact on Quality of Life

This study has been completed.

Sponsor:

Information provided by:

North Shore Long Island Jewish Health System

ClinicalTrials.gov Identifier:

NCT01360983

First received: May 24, 2011

Last updated: May 25, 2011

Last verified: April 2010

History of Changes

Purpose

This is a research study to determine the prevalence of Vitamin B 12 deficiency in end stage renal disease patients that are on hemodialysis. 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.

Condition	Intervention
Vitamin B 12 Deficiency End Stage Renal Disease	Drug: Vitamin B12 injections monthly

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Impact of Vitamin b12 Replacement on Epogen Requirements in Hemodialysis Patients and Impact on Quality of Life

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Dialysis Kidney Failure

Drug Information available for: Cyanocobalamin Vitamin B Complex Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Improve epogen requirements [ Time Frame: within 3 months of using b12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: within 3 months of supplementation ] [ Designated as safety issue: No ]
using KQOL SF36 determine improvement of quality of life post b12 supplementation

Enrollment:	57
Study Start Date:	July 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B12 Deficient patients	Drug: Vitamin B12 injections monthly 1000mcg of vitamin b12 will be injected in the deltoid muscle weekly for 4 weeks then monthly for a total of 4 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
ETOH use greater then 2 drinks per day
Vegetarian Diet
Gastric Surgery
Inflammatory Bowel Disease
Pernicious Anemia
Recent transfusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360983

Locations

United States, New York
Island Rehabilitative Services
Staten Island, New York, United States, 10305

Sponsors and Collaborators

Staten Island University Hospital

Investigators

Study Director:

Norbert Shtaynberg

Staten Island Hospital

More Information

Publications:

Green R, Kinsella LJ. Current concepts in the diagnosis of cobalamin deficiency. Neurology. 1995 Aug;45(8):1435-40. Review. No abstract available.

Herrmann W, Schorr H, Geisel J, Riegel W. Homocysteine, cystathionine, methylmalonic acid and B-vitamins in patients with renal disease. Clin Chem Lab Med. 2001 Aug;39(8):739-46.

Obeid R, Kuhlmann MK, Köhler H, Herrmann W. Response of homocysteine, cystathionine, and methylmalonic acid to vitamin treatment in dialysis patients. Clin Chem. 2005 Jan;51(1):196-201. Epub 2004 Nov 4.

Zachee P, Chew SL, Daelemans R, Lins RL. Erythropoietin resistance due to vitamin B12 deficiency. Case report and retrospective analysis of B12 levels after erythropoietin treatment. Am J Nephrol. 1992;12(3):188-91.

Responsible Party:	Suzanne El-Sayegh, Staten Island Hospital
ClinicalTrials.gov Identifier:	NCT01360983 History of Changes
Other Study ID Numbers:	09024B12
Study First Received:	May 24, 2011
Last Updated:	May 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

Hemodialysis patients

Additional relevant MeSH terms:

Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic

Renal Insufficiency
Avitaminosis
Malnutrition
Nutrition Disorders
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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