Back to resultsTocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alpha, gamma, beta, and delta (mixed) tocopherols
alpha lipoic acid
placebo
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: AIDS (HIV seropositivity is not an exclusion criteria) 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. Pregnant women
Sites / Locations
- Maine Medical Center
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker
Secondary Outcome Measures
A significant change in biomarkers of acute inflammation and oxidative stress from serum
A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00308971
Brief Title
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Official Title
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alpha, gamma, beta, and delta (mixed) tocopherols
Other Intervention Name(s)
Vitamin E
Intervention Description
approximately 666 IU daily (1 pill) for 4 months
Intervention Type
Drug
Intervention Name(s)
alpha lipoic acid
Intervention Description
600 mg daily (2 pills 300 mg each) for 4 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo for alpha lipoic acid; 2 pills daily for 4 months
Primary Outcome Measure Information:
Title
A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker
Time Frame
4 months
Secondary Outcome Measure Information:
Title
A significant change in biomarkers of acute inflammation and oxidative stress from serum
Time Frame
4 months
Title
A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
AIDS (HIV seropositivity is not an exclusion criteria)
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.
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Himmelfarb, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
We'll reach out to this number within 24 hrs