Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome

NCT06659406 | Not Yet Recruiting

• 1 other identifier: Tuf/IRB/275/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are: Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome. Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

PCOS

Outcome Measures

Primary Outcomes (2)

• effect of coenzyme q10 administration on polycystic ovary syndrome

  Improvement in levels of oxidative stress , inflammatory and hyperandrogenism biomarkers in women with Polycystic ovary syndrome

  from enrollment to the end of treatment at 12 weeks

• The effect of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome

  Oxidative stress in PCOS is leads to imbalance in antioxidant and oxidant levels in the body, along with production of reactive oxygen species. Insulin resistance has a key role in the PCOS pathogenesis by promoting oxidative stress and promoting acute and chronic Inflammation. Studies have shown that inflammatory markers are raised in PCOS along with decreased levels of anti-inflammatory biomarkers. Coenzyme Q10 is a natural vitamin, acts as an antioxidant, have shown an constructive impact on inflammatory and endothelial dysfunction biomarkers and also effects androgen levels. Effect of Coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism will be accessed by biomarkers Malondialdehyde MDA, C-reactive protein CRP and Sex hormone binding globulin SHBG. Ideally levels of MDA, CRP would decrease and SHBG levels would increase after Coenzyme Q10 supplementation. This study would measure these three biomarkers before and after the intervention.

  from enrollment to the end of treatment at 12 weeks

Study Arms (1)

CoQ-10 supplementation

EXPERIMENTAL

The experimental arm will consist of fertile females diagnosed with polycystic ovary syndrome aged between 18 to 50 years. Patients with diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function, autoimmune and Inflammatory disorders will be excluded.

Dietary Supplement: Coenzyme Q10

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10 will be given once daily, 200mg for the period of 3 months

Also known as: ubiquinone

CoQ-10 supplementation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: biological females would be accepted because this condition effects ovaries that are present in biological females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Married Patients that presented with anovulatory infertility due to PCOS.
• Unmarried Patients that presented with symptoms due to PCOS
• All patients should fulfill Rotterdam criteria for PCOS

You may not qualify if:

• Male factor infertility ( oligospermia or aspermia)
• Tubal factor infertility (abnormal hysterosalpingography)
• Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
• Autoimmune and Inflammatory disorders
• Abnormal serum prolactin level
• Smokers
• Alcoholic beverage use
• Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements

Sponsors & Collaborators

• University of Faisalabad: lead
• College of Physicians and Surgeons Pakistan: collaborator

Study Sites (1)

Madinah Teaching Hospital

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (1)

• Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.

  PMID: 38025704 BACKGROUND

Related Links

• Efficacy of coenzyme Q10 supplementation on glucose metabolism, lipid profiles, and biomarkers of inflammation in women with polycystic ovary syndrome

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Sana Akram, MBBS, FCPS

  University of Faisalabad

  STUDY DIRECTOR

Central Study Contacts

hira zahid, MBBS, M.Phil.

CONTACT

+923237624565; drhirazahid@yahoo.com

Sana Akram, MBBS, FCPS

CONTACT

+923334577182; sana.akram1986@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 26, 2024
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)