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

March 21, 2024 updated by: Uriach Consumer Healthcare

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • Medical Center Teknon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The data will be collected from patients who meet the selection criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
Time Frame: 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).
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uriach Consumer Healthcare

Investigators

  • Principal Investigator: Javier Albares, Doctor, Centro Médico Teknon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2020

Primary Completion (Actual)

June 2, 2021

Study Completion (Actual)

June 2, 2021

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPOICSPI2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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