Coenzyme Q10 in Juvenile Idiopathic Arthritis Patients

NCT05871086 | Unknown Phase 2

• 1 other identifier: ACUCFPASURHDIRB2020110301#169
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatological disorder in childhood of unknown cause and a major cause of functional disability. Standard JIA treatment including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, methotrexate, and biological agents have considerable adverse effects in addition to their high cost. Despite the success of these treatment approaches, patients may still have active disease with other sequelae from chronic inflammation and considerable morbidity that may negatively impact patients' quality of life. Therefore, evaluating the potential benefit of alternative add-on anti-inflammatories and antioxidants might be a promising area for further research. Coenzyme Q10 (CoQ10) is a natural mitochondrial electron carrier and a powerful lipophilic antioxidant located in almost all cell membranes and plasma lipoproteins. Several preclinical studies in animal models as well as clinical trials in adult patients with rheumatoid arthritis (RA) have demonstrated the beneficial effects of CoQ10. Results show that CoQ10 can reduce the oxidative and inflammatory status as well as clinical features that characterize this systemic autoimmune disease. Also, CoQ10 has been used safely in children before and was well tolerated. Thus, the investigators would like to evaluate the effect of CoQ10 oral supplementation in pediatric JIA patients.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Disease Activity Evaluation

  Clinical efficacy will be assessed by calculating the Clinical Juvenile Arthritis Disease Activity Score (cJADAS-10) at baseline and at the end of the 3-month trial period. The cJADAS is computed by assessing the following variables: 1. Physician's global rating of overall disease activity 2. Parent/child ratings of well-being 3. Counts of active joints assessed in 10 joints

  3 months

Secondary Outcomes (5)

• Serum Malondialdehyde

  3 months

• Serum Tumor necrosis factor-alpha

  3 months

• Safety of Coenzyme Q10

  3 months

• The Childhood Health Assessment Questionnaire (CHAQ)

  3 months

• serum glutathione

  3 months

Study Arms (2)

Coenzyme Q10 Group

EXPERIMENTAL

Patients will receive their JIA standard treatment plus 100 mg Coenzyme Q10 capsules daily for 3 months.

Dietary Supplement: Coenzyme Q10; Drug: Standard Regimen

Control Group

PLACEBO COMPARATOR

Patients will receive their standard JIA treatment plus placebo

Other: Placebo; Drug: Standard Regimen

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10 soft gelatin capsules daily for 3 months

Coenzyme Q10 Group

Placebo OTHER

Placebo Capsules

Control Group

Standard Regimen DRUG

Patients may be receiving any of these commonly used JIA treatments including: * Ibuprofen - 30 to 40 mg/kg/day in 3 to 4 divided doses * Diclofenac - 2 to 3 mg/kg/day in divided doses 2 to 3 times daily * Methotrexate - Initial: 10 to 15 mg/m2 once weekly; adjust gradually up to 20 to 30 mg/m2 once weekly * Leflunomide - Weight based, 10-20 mg once daily * Sulfasalazine - 30 to 50 mg/kg/day in 2 divided doses * Etanercept - 0.8 mg/kg/dose once weekly * Adalimumab - Weight based, 10-40 mg every other week

Coenzyme Q10 Group; Control Group

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients (\<16 years old)
• Diagnosed with active JIA according to the American College of Rheumatology (ACR) 2019 guideline.
• Patients with peripheral oligo or polyarthritis.
• With more than 6-month disease duration
• Participants who have inadequate response to at least one first line standard therapy.
• Patients who have been receiving a stable treatment regimen for the past 3 months

You may not qualify if:

• Patients with active systemic JIA
• Patients presenting with complications (such as amyloidosis, uveitis, or glomerulonephritis)
• Patients with other chronic autoimmune disease.

Sponsors & Collaborators

• Nourhan Elsherif: lead

Study Sites (1)

Pediatric Allergy, Immunology, Rheumatology Clinic, Children's Hospital, Ain Shams University Hospital

Cairo, Egypt

RECRUITING

Related Publications (19)

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  PMID: 21684384 BACKGROUND

• Giancane G, Consolaro A, Lanni S, Davi S, Schiappapietra B, Ravelli A. Juvenile Idiopathic Arthritis: Diagnosis and Treatment. Rheumatol Ther. 2016 Dec;3(2):187-207. doi: 10.1007/s40744-016-0040-4. Epub 2016 Aug 12.

  PMID: 27747582 BACKGROUND

• Zaripova LN, Midgley A, Christmas SE, Beresford MW, Baildam EM, Oldershaw RA. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021 Aug 23;19(1):135. doi: 10.1186/s12969-021-00629-8.

  PMID: 34425842 BACKGROUND

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  PMID: 31021516 BACKGROUND

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  PMID: 14760812 BACKGROUND

• Bentinger M, Tekle M, Dallner G. Coenzyme Q--biosynthesis and functions. Biochem Biophys Res Commun. 2010 May 21;396(1):74-9. doi: 10.1016/j.bbrc.2010.02.147.

  PMID: 20494114 BACKGROUND

• Lopez-Pedrera C, Villalba JM, Patino-Trives AM, Luque-Tevar M, Barbarroja N, Aguirre MA, Escudero-Contreras A, Perez-Sanchez C. Therapeutic Potential and Immunomodulatory Role of Coenzyme Q10 and Its Analogues in Systemic Autoimmune Diseases. Antioxidants (Basel). 2021 Apr 13;10(4):600. doi: 10.3390/antiox10040600.

  PMID: 33924642 BACKGROUND

• Jhun J, Moon J, Ryu J, Shin Y, Lee S, Cho KH, Kang T, Cho ML, Park SH. Liposome/gold hybrid nanoparticle encoded with CoQ10 (LGNP-CoQ10) suppressed rheumatoid arthritis via STAT3/Th17 targeting. PLoS One. 2020 Nov 6;15(11):e0241080. doi: 10.1371/journal.pone.0241080. eCollection 2020.

  PMID: 33156836 BACKGROUND

• Jhun J, Lee S, Kim SY, Na HS, Kim EK, Kim JK, Jeong JH, Park SH, Cho ML. Combination therapy with metformin and coenzyme Q10 in murine experimental autoimmune arthritis. Immunopharmacol Immunotoxicol. 2016;38(2):103-12. doi: 10.3109/08923973.2015.1122619. Epub 2015 Dec 17.

  PMID: 26681425 BACKGROUND

• Bauerova K, Paulovicova E, Mihalova D, Drafi F, Strosova M, Mascia C, Biasi F, Rovensky J, Kucharska J, Gvozdjakova A, Ponist S. Combined methotrexate and coenzyme Q(1)(0) therapy in adjuvant-induced arthritis evaluated using parameters of inflammation and oxidative stress. Acta Biochim Pol. 2010;57(3):347-54. Epub 2010 Sep 9.

  PMID: 20827446 BACKGROUND

• Tawfik MK. Combination of coenzyme Q10 with methotrexate suppresses Freund's complete adjuvant-induced synovial inflammation with reduced hepatotoxicity in rats: Effect on oxidative stress and inflammation. Int Immunopharmacol. 2015 Jan;24(1):80-7. doi: 10.1016/j.intimp.2014.11.018. Epub 2014 Dec 3.

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• Nachvak SM, Alipour B, Mahdavi AM, Aghdashi MA, Abdollahzad H, Pasdar Y, Samadi M, Mostafai R. Effects of coenzyme Q10 supplementation on matrix metalloproteinases and DAS-28 in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial. Clin Rheumatol. 2019 Dec;38(12):3367-3374. doi: 10.1007/s10067-019-04723-x. Epub 2019 Aug 7.

  PMID: 31392559 BACKGROUND

• Abdollahzad H, Aghdashi MA, Asghari Jafarabadi M, Alipour B. Effects of Coenzyme Q10 Supplementation on Inflammatory Cytokines (TNF-alpha, IL-6) and Oxidative Stress in Rheumatoid Arthritis Patients: A Randomized Controlled Trial. Arch Med Res. 2015 Oct;46(7):527-33. doi: 10.1016/j.arcmed.2015.08.006. Epub 2015 Sep 3.

  PMID: 26342738 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

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  PMID: 24980508 BACKGROUND

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  PMID: 7986222 BACKGROUND

• el Miedany YM, Youssef SS, el Gaafary M. Cross cultural adaptation and validation of the Arabic version of the Childhood Health Assessment Questionnaire for measuring functional status in children with juvenile idiopathic arthritis. Clin Exp Rheumatol. 2003 May-Jun;21(3):387-93.

  PMID: 12846063 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Nourhan N Elsherif

CONTACT

00201119793161; nourhan.nasser18@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo will be given to patients in the control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacy Master's Candidate

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 23, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)