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Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133664
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : May 3, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Cognition
Interventions Drug: lipoic acid and omega-3 fatty acids
Drug: Placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details 49 participants were excluded from the study for the following: did not meet inclusion criteria (i.e. test scores too high, colorblindness, unclear cognitive status), declined to participate, could not consent, lost to follow-up, and started fish oil.
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Period Title: Overall Study
Started 26 28
Completed 21 21
Not Completed 5 7
Reason Not Completed
Lost to Follow-up             2             1
Adverse Event             3             6
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo Total
Hide Arm/Group Description

lipoic acid and omega-3 fatty acids

Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Total of all reporting groups
Overall Number of Baseline Participants 26 28 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  96.2%
28
 100.0%
53
  98.1%
>=65 years
1
   3.8%
0
   0.0%
1
   1.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 54 participants
49.34  (10.91) 52.96  (8.85) 51.22  (9.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Female
23
  88.5%
21
  75.0%
44
  81.5%
Male
3
  11.5%
7
  25.0%
10
  18.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 28 participants 54 participants
26 28 54
1.Primary Outcome
Title Paced Auditory Serial Addition Task (PASAT)
Hide Description The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed PASAT at both baseline and 12 weeks were analyzed.
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: correct responses
2.24  (4.69) 3.38  (5.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lipoic Acid and Omega-3 Fatty Acids, Placebo
Comments With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
-2.03 to 4.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.57
Estimation Comments [Not Specified]
2.Primary Outcome
Title Stroop Color-Word Test
Hide Description The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word "yellow" may be red, the word "blue" may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis occurs only for participants who completed Stroop at both baseline and 12 weeks
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: seconds
-5.59  (12.77) -2.87  (7.01)
3.Primary Outcome
Title California Verbal Learning Test-II (CVLT-II)
Hide Description CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of "shopping list" items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed CVLT-II at baseline and 12 weeks were analyzed
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: correct responses
1.57  (1.85) 1.65  (2.44)
4.Primary Outcome
Title Controlled Oral Word Association Test (COWAT)
Hide Description The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participant who completed COWAT at both baseline and 12 weeks were analyzed
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and omega-3 fatty acids

lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: words
0.70  (7.71) 0.39  (7.14)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

lipoic acid and omega-3 fatty acids

Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid

placebo oil and placebo lipoic acid

Placebo: placebo lipoic acid and placebo oil

All-Cause Mortality
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/26 (7.69%)   0/28 (0.00%) 
Ear and labyrinth disorders     
Deafness unilateral  1 [1]  1/26 (3.85%)  0/28 (0.00%) 
Renal and urinary disorders     
Kidney Infection  1 [2]  1/26 (3.85%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
[1]
Participant went on an airplane- during descent, lost hearing in right ear.
[2]
Hospitalized 7/6/15-7/10/15 and treated for kidney infection and dehydration.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/26 (80.77%)   12/28 (42.86%) 
Gastrointestinal disorders     
Throat irritation  1 [1]  3/26 (11.54%)  0/28 (0.00%) 
Dysphagia  1 [2]  0/26 (0.00%)  2/28 (7.14%) 
Adverse drug reaction  1 [3]  2/26 (7.69%)  0/28 (0.00%) 
Dyspepsia  1 [4]  4/26 (15.38%)  1/28 (3.57%) 
Nausea  1  6/26 (23.08%)  2/28 (7.14%) 
General disorders     
Fatigue  1  3/26 (11.54%)  1/28 (3.57%) 
Injury, poisoning and procedural complications     
Fall  1  0/26 (0.00%)  4/28 (14.29%) 
Nervous system disorders     
Headache  1  2/26 (7.69%)  0/28 (0.00%) 
Renal and urinary disorders     
Urine odor abnormal  1 [5]  4/26 (15.38%)  0/28 (0.00%) 
Incontinence  1  2/26 (7.69%)  1/28 (3.57%) 
Urinary tract infection  1  2/26 (7.69%)  1/28 (3.57%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
[1]
Burning in throat
[2]
Difficulty swallowing study supplement
[3]
Fishy taste, fish burps
[4]
Indigestion
[5]
Strong odor to urine
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
Phone: 503-494-5035
EMail: shintol@ohsu.edu
Layout table for additonal information
Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02133664    
Other Study ID Numbers: PP2190
First Submitted: May 6, 2014
First Posted: May 8, 2014
Results First Submitted: March 22, 2017
Results First Posted: May 3, 2017
Last Update Posted: June 2, 2017