Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

NCT00004495 | Completed

• 2 other identifiers: 199/14276GUMC-FDR001544
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total homocysteine concentration in patients with end stage renal disease receiving regular hemodialysis therapy resulting in hyperhomocysteinemia. II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) daily in these patients. III. Assess the safety and tolerability of this therapy in these patients.

Conditions

End Stage Renal Disease; Hyperhomocysteinemia

Keywords

cardiovascular and respiratory diseases; end stage renal disease; hyperhomocysteinemia; rare disease; renal and genitourinary disorders

Interventions

cyanocobalamin DRUG

folic acid DRUG

pyridoxine DRUG

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Diagnosis of end stage renal disease requiring regular hemodialysis treatment 3 times weekly * Baseline predialysis total homocysteine concentration in plasma greater than 16 micromoles/L * No prior or concurrent pernicious anemia * No blood smear examination showing unexplained macrocytosis --Prior/Concurrent Therapy-- * Chemotherapy: No concurrent chemotherapy for cancer * Other: No concurrent levodopa or carbidopa No concurrent penicillamine or trimethoprim-sulfonamide combination No concurrent antiviral therapy No concurrent anticonvulsants --Patient Characteristics-- * Hematopoietic: Hematocrit at least 25% * Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No Parkinson's disease No convulsions or epilepsy requiring treatment No lactose intolerance or allergy to milk products No history of allergic sensitization following administration of folic acid, pyridoxine (vitamin B6), or cyanocobalamin (vitamin B12) No vitamin B12 concentration below lower limit of normal (150 picamole/L) No untreated hypothyroidism or psoriasis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperhomocysteinemia; Respiratory Tract Diseases; Rare Diseases; Urogenital Diseases

Interventions

Vitamin B 12; Folic Acid; Pyridoxine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

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; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Vitamin B 6; Picolines; Pyridines

Study Officials

• Christopher S. Wilcox

  Georgetown University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: June 1, 1999
• Study Completion: September 1, 2000
• Last Updated: March 25, 2015

Record last verified: 1999-08

Locations

US (1)