Trial Outcomes & Findings for Provision of Antioxidant Therapy in Hemodialysis (PATH) Study (NCT NCT00237718)
NCT ID: NCT00237718
Last Updated: 2012-01-11
Results Overview
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
385 participants
Primary outcome timeframe
month 6
Results posted on
2012-01-11
Participant Flow
This study was conducted at the Vanderbilt University Medical Center and at Fresenius Medical Care North America Dialysis clinics between April 2006 and September 2010.
There is a 1-month period between enrollment and assignment to a treatment group. Although 385 subjects were enrolled, only 356 were randomized (29 subjects withdrew consent prior to randomization). Also, 31 subjects were administratively withdrawn (due to widespread protocol non-compliance at one site) leaving 325 subjects assigned to a group.
Participant milestones
| Measure |
ALA and Vitamin E
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
165
|
|
Overall Study
COMPLETED
|
114
|
124
|
|
Overall Study
NOT COMPLETED
|
46
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Baseline characteristics by cohort
| Measure |
ALA and Vitamin E
n=160 Participants
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
n=165 Participants
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58 years
STANDARD_DEVIATION 12 • n=5 Participants
|
58 years
STANDARD_DEVIATION 13 • n=7 Participants
|
58 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
98 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: month 6Population: The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
Outcome measures
| Measure |
ALA and Vitamin E
n=109 Participants
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
n=121 Participants
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
|---|---|---|
|
F2-isoprostane (F2-iso)
|
0.077 ng/ml
Standard Deviation 0.062
|
0.073 ng/ml
Standard Deviation 0.055
|
SECONDARY outcome
Timeframe: month 6Population: The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.
IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.
Outcome measures
| Measure |
ALA and Vitamin E
n=109 Participants
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
n=121 Participants
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
|---|---|---|
|
Interleukin-6 (IL-6)
|
19 pg/ml
Standard Deviation 15
|
20 pg/ml
Standard Deviation 27
|
Adverse Events
ALA and Vitamin E
Serious events: 44 serious events
Other events: 91 other events
Deaths: 0 deaths
Placebo
Serious events: 52 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALA and Vitamin E
n=160 participants at risk
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
n=165 participants at risk
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
|---|---|---|
|
Cardiac disorders
cardiac
|
6.9%
11/160 • Number of events 13 • 6 months
|
4.8%
8/165 • Number of events 13 • 6 months
|
|
Infections and infestations
infection
|
4.4%
7/160 • Number of events 7 • 6 months
|
7.9%
13/165 • Number of events 14 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary
|
3.8%
6/160 • Number of events 7 • 6 months
|
1.8%
3/165 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
GI upset
|
2.5%
4/160 • Number of events 6 • 6 months
|
2.4%
4/165 • Number of events 4 • 6 months
|
|
Vascular disorders
access related
|
1.2%
2/160 • Number of events 4 • 6 months
|
2.4%
4/165 • Number of events 4 • 6 months
|
|
Cardiac disorders
fluid overload
|
0.00%
0/160 • 6 months
|
3.0%
5/165 • Number of events 5 • 6 months
|
|
Endocrine disorders
diabetes
|
0.62%
1/160 • Number of events 1 • 6 months
|
0.61%
1/165 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
edema
|
0.00%
0/160 • 6 months
|
0.61%
1/165 • Number of events 3 • 6 months
|
|
Vascular disorders
hypertension/hypotension
|
1.2%
2/160 • Number of events 2 • 6 months
|
0.61%
1/165 • Number of events 1 • 6 months
|
|
Nervous system disorders
neurological
|
1.2%
2/160 • Number of events 2 • 6 months
|
0.61%
1/165 • Number of events 1 • 6 months
|
|
Infections and infestations
viral infection
|
0.00%
0/160 • 6 months
|
1.8%
3/165 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
1.2%
2/160 • Number of events 2 • 6 months
|
0.00%
0/165 • 6 months
|
|
Metabolism and nutrition disorders
electrolyte disorder
|
1.2%
2/160 • Number of events 2 • 6 months
|
0.00%
0/165 • 6 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
0.00%
0/160 • 6 months
|
1.2%
2/165 • Number of events 2 • 6 months
|
|
General disorders
pain
|
0.00%
0/160 • 6 months
|
1.2%
2/165 • Number of events 2 • 6 months
|
|
General disorders
dizziness
|
0.00%
0/160 • 6 months
|
0.61%
1/165 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
lesions
|
0.62%
1/160 • Number of events 1 • 6 months
|
0.00%
0/165 • 6 months
|
|
General disorders
trauma
|
0.00%
0/160 • 6 months
|
0.61%
1/165 • Number of events 1 • 6 months
|
|
General disorders
other
|
2.5%
4/160 • Number of events 4 • 6 months
|
1.2%
2/165 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
ALA and Vitamin E
n=160 participants at risk
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
|
Placebo
n=165 participants at risk
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
|
|---|---|---|
|
Gastrointestinal disorders
GI upset
|
27.5%
44/160 • Number of events 63 • 6 months
|
20.0%
33/165 • Number of events 44 • 6 months
|
|
Infections and infestations
infection
|
20.0%
32/160 • Number of events 38 • 6 months
|
21.8%
36/165 • Number of events 48 • 6 months
|
|
Vascular disorders
access related
|
13.8%
22/160 • Number of events 44 • 6 months
|
9.1%
15/165 • Number of events 25 • 6 months
|
|
General disorders
pain
|
8.8%
14/160 • Number of events 18 • 6 months
|
11.5%
19/165 • Number of events 27 • 6 months
|
|
Infections and infestations
viral infection
|
9.4%
15/160 • Number of events 19 • 6 months
|
11.5%
19/165 • Number of events 22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary
|
7.5%
12/160 • Number of events 18 • 6 months
|
7.3%
12/165 • Number of events 14 • 6 months
|
|
Cardiac disorders
cardiac
|
7.5%
12/160 • Number of events 15 • 6 months
|
6.7%
11/165 • Number of events 15 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place