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Effect of Alpha-lipoic Acid on Regression of Low-grade Squamous Intraepithelial Lesions (LSIL)

NCT05485259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-03

No results posted yet for this study

Summary

Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions.

The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA.

The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.

Conditions

  • Low-Grade Squamous Intraepithelial Lesions

Interventions

DIETARY_SUPPLEMENT

DL-alpha lipoic acid

Treatment group recieves 600 mg of DL-alpha lipoic acid daily, per os, for 3 months.

OTHER

placebo (rice starch)

Placebo group recieves 600 mg (2x300 mg) of placebo (rice starch) daily, per os, for 3 months

Sponsors & Collaborators

  • University Clinical Center Tuzla

    collaborator OTHER

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Dubravka Vitali Čepo, prof · University of Zagreb, Faculty of Pharmacy and Biochemistry

  • Zinaida Karasalihović, prof · University Clinical Center Tuzla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2022-01-15
Completion
2022-06-15

Countries

  • Bosnia and Herzegovina
  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485259 on ClinicalTrials.gov