Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

NCT00308971 | Completed Phase 2

• 1 other identifier: 051000
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker

  4 months

Secondary Outcomes (2)

• A significant change in biomarkers of acute inflammation and oxidative stress from serum

  4 months

• A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography

  4 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Alpha, gamma, beta, and delta (mixed) tocopherols; Drug: alpha lipoic acid

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Alpha, gamma, beta, and delta (mixed) tocopherols DRUG

approximately 666 IU daily (1 pill) for 4 months

Also known as: Vitamin E

1

alpha lipoic acid DRUG

600 mg daily (2 pills 300 mg each) for 4 months

1

placebo DRUG

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Stage III-IV chronic kidney disease measured by MDRD formula.
• age \> 18 or \< 75 years.
• Life expectancy greater than one year.
• Ability to understand and provide informed consent for participation in the study

You may not qualify if:

• Active hepatitis C or B
• Active gout
• Other active inflammatory diseases.
• Active malignancy excluding basal or squamous cell carcinoma of the skin.
• Gastrointestinal dysfunction requiring parental nutrition.
• History of functional kidney transplant \< 6 months prior to study entry.
• Anticipated live donor kidney transplant over study duration.
• Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
• Patients taking Vitamin E supplements \> 60 IU/day, vitamin C\> 500mg/day over the past 30days.
• Patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days.
• Patient taking any prednisone therapy.
• More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days.
• On experimental drug protocols.
• Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
• Hypersensitivity to vitamin E or alpha lipoic acid.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (2)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Gamma Rays; YY1 Transcription Factor; Tocopherols; Vitamin E; Thioctic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Erythroid-Specific DNA-Binding Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Jonathan Himmelfarb, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Alp Ikizler, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 30, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 9, 2009

Record last verified: 2009-07

Locations

US (2)