Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT06324760
• Lead Sponsor: Uriach Consumer Healthcare

Brief Summary

Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.

Detailed Description

Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.

Study Timeline

• Study Start: 2020-03-04
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participants must be a minimum of 18 years of age.
• They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
• They need to provide explicit consent via an informed consent document.

Exclusion Criteria

• Patients diagnosed with pathologies other than RLS that affect sleep quality.
• Those with persistent renal diseases or any other chronic, severe medical condition.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)	6 months	This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).

Secondary Outcome Measures

Name	Time	Method
Anthropometric parameters of the patients.	6 Months	Weight (kg).
Patients' body measurements	6 Months	Body mass index (BMI) (kg/m²).
Measurements of patient anatomy.	6 Months	Muscle mass (kg).
Measurements of patient anatomy	6 Months	Total fat mass (kg).
Patients' body characteristics.	6 Months	Visceral fat mass (kg).

Trial Locations

Locations (1)

Medical Center Teknon; 🇪🇸 Barcelona, Spain