Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis

Sponsor
Rebecca Spain (Other)
Overall Status
Completed
CT.gov ID
NCT03493841
Collaborator
(none)
20
1
2
7.6
2.6

Study Details

Study Description

Brief Summary

This is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: R form and racemic form.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alpha Lipoic Acid
Phase 1

Detailed Description

This three-week double-blind crossover trial will compare two different forms of lipoic acid (LA). Every participant will take one week of daily oral 600mg R LA, have a one week washout period without LA, and take one week of daily oral 1200mg racemic LA. The order of LA type will be determined by randomization. Blood analyses will be performed to determine which form is better absorbed and a side effects questionnaire will be completed at each visit in order to determine which form is better tolerated.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial
Actual Study Start Date :
Jun 8, 2018
Actual Primary Completion Date :
Jan 25, 2019
Actual Study Completion Date :
Jan 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Group A will receive racemic lipoic acid first and R-lipoic acid second

Drug: Alpha Lipoic Acid
Lipoic acid is an over the counter supplement. Two different forms, R and racemic are available. R-lipoic acid is the naturally occurring form. Racemic lipoic acid is the most commonly available supplement.
Other Names:
  • lipoic acid
  • R-lipoic acid
  • Experimental: Group B

    Group B will receive R- lipoic acid first and racemic lipoic acid second

    Drug: Alpha Lipoic Acid
    Lipoic acid is an over the counter supplement. Two different forms, R and racemic are available. R-lipoic acid is the naturally occurring form. Racemic lipoic acid is the most commonly available supplement.
    Other Names:
  • lipoic acid
  • R-lipoic acid
  • Outcome Measures

    Primary Outcome Measures

    1. Comparison of oral tolerance between R-LA and racemic LA [Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.]

      Oral tolerance will be determined by the completion of a modified Monitoring of Side Effects Scale at each study visit. This scale asks the participant to rate the following side effects: abdominal pain, appetite: decreased, appetite: increased, constipation, diarrhea, flatulence, nausea/vomiting, taste abnormality (metallic, etc.), thirst: increased, thirst: decreased, and weight: increased. Each side effect will be rated on severity. 0 - the lowest possible score represents "not present". 4 - the highest possible score represents "severe". The relative change in total tolerance score will be compared between R-LA and racemic LA.

    2. Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA [Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.]

      Serum bioavailability, as measured by Area Under the Curve (0-infinity) will be compared between R-LA and racemic LA by obtaining concentration values at times 0, 60, 90, 120, 180, and 240 minutes after ingestion of LA dose on the first (visits 1 and 3) and last doses (visits 2 and 4) of each LA form.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of Progressive Multiple Sclerosis

    • 18 years of age or older

    • Able to give informed consent and adhere to the study activities

    • Able to swallow large oral capsules

    Exclusion Criteria:
    • Clinical Multiple Sclerosis relapse in the prior 1 year

    • Oral or IV steroids in the prior 3 months

    • Have taken LA in last 30 days

    • Clinically significant kidney disease as determined by the PI including, but not limited to, major kidney disease diagnoses, abnormal laboratory values related to renal function, or other related conditions

    • Insulin-dependent diabetes

    • Other significant ongoing medical illness that may interfere with study procedures

    • Taking oral anticoagulants (e.g. Coumadin). Aspirin, clopidogrel, and dipyridamole are acceptable to take

    • Pregnant or breast-feeding

    • Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Rebecca Spain

    Investigators

    • Principal Investigator: Rebecca Spain, MD, MSPH, Oregon Health and Science University
    • Principal Investigator: Michelle Cameron, MD, PT, MCR, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebecca Spain, Principal Investigator, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03493841
    Other Study ID Numbers:
    • IRB #17951
    First Posted:
    Apr 11, 2018
    Last Update Posted:
    Mar 22, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2019