NCT03493841

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rebecca Spain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis
• Progressive Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis
• Primary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-08
• Primary completion: 2019-01-25
• Completion: 2019-01-25
• First posted: 2018-04-11
• Last updated: 2019-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study