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

Restless Legs Syndrome Clinical Trial

Official title:

Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06324760
• Other study ID #: LIPOICSPI2018
• Status: Completed
• Start date: March 4, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: March 2024
• Source: Uriach Consumer Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Alpha-lipoic acid combined with B vitamins
The investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system

Locations

Country	Name	City	State
Spain	Medical Center Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Uriach Consumer Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)	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).	6 months
Secondary	Anthropometric parameters of the patients.	Weight (kg).	6 Months
Secondary	Patients' body measurements	Body mass index (BMI) (kg/m²).	6 Months
Secondary	Measurements of patient anatomy	Total fat mass (kg).	6 Months
Secondary	Patients' body characteristics.	Visceral fat mass (kg).	6 Months
Secondary	Measurements of patient anatomy.	Muscle mass (kg).	6 Months