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Completed

NCT Number: NCT06324760

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

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

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Teknon

Barcelona, 08017, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alpha-lipoic acid combined with B vitamins

Dietary Supplement

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Anthropometric parameters of the patients.

    Time frame: 6 Months

    Weight (kg).

  2. Patients' body measurements

    Time frame: 6 Months

    Body mass index (BMI) (kg/m²).

  3. Measurements of patient anatomy

    Time frame: 6 Months

    Total fat mass (kg).

  4. Patients' body characteristics.

    Time frame: 6 Months

    Visceral fat mass (kg).

  5. Measurements of patient anatomy.

    Time frame: 6 Months

    Muscle mass (kg).

Sponsors and collaborators

Lead sponsor

Uriach Consumer Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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