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

Multiple Sclerosis Clinical Trial

Official title:

Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493841
• Other study ID #: IRB #17951
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: March 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Primary Progressive Multiple Sclerosis
• Progressive Multiple Sclerosis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Rebecca Spain

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of oral tolerance between R-LA and racemic LA	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.	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.
Primary	Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA	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.	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.