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The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated October 17, 2024 (before its estimated July 22, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria shortened, about 114 words
    • Study description shortened, about 1,249 words
    • Site details revised
    • Study title shortened, about 9 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Abstract Background: This trial aims to investigate the effect of 12 weeks of 10 mg/day astaxanthin (ASX) administration compared with the control group on insulin sensitivity, lipid profile, circulating MDA levels, severity of hirsutism, and depression in women with Polycystic Ovary Syndrome (PCOS). Methods: This manuscript will outline the design, methodology, and potential clinical implications of ASX supplementation in eligible women with PCOS and a body mass index of 25-35 kg/m2, who are referred to the gynecologist clinic in Isfahan, Iran, during 2024-2025. Discussion: This study is one of the first attempts to assess the clinical efficacy of astaxanthin as an auxiliary treatment in PCOS patients, and will provide more evidence in this area. Trial registration number: Iran Clinical Trials (IRCT) website. (IRCT20231001059573N1)
Trial Details
NCT Number NCT06642363
Lead Sponsor Isfahan University of Medical Sciences
Conditions
(from sponsor)		 PCO - Polycystic Ovaries, Obesity and Obesity-related Medical Conditions
Related terms Hirsutism, Obesity, Polycystic Ovary Syndrome
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov