The Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus

Evaluation of the Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07096557

Enrollment

Registered

2025-07-31

Start date

2024-01-01

Completion date

2025-02-10

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

The goal of this clinical trial is to evaluate the safety and efficacy of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are: * What is the impact of coenzyme Q10 supplementation on mitochondrial dysfunction? * Does it have a beneficial effect on disease activity through assessment of the systemic lupus erythematosus disease activity index (SLEDAI) score? Researchers will compare the group of patients that take coenzyme Q10 to a group that doesn't to see if coenzyme Q10 supplementation works to decrease mitochondrial dysfunction and disease activity. Participants will: Take coenzyme Q10 plus the standard treatment of SLE or the standard treatment only every day for 3 months. Visit the clinic once every 4 weeks for checkups and tests.

Interventions

DRUGCoenzyme Q10

Coenzyme Q10 100 mg capsule once daily for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

Inclusion criteria

1. Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE. 2. Patients with moderate to severe activity presenting with lupus nephritis.

Exclusion criteria

1. Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine, or vitamin C. 2. Patients with very severe active SLE that might threaten vital organs. 3. Patients with chronic infections and severe and recurrent infections, whether bacterial, viral, or fungal infection

Design outcomes

Primary

Measure	Time frame	Description
Mitochondrial dysfunction	3 months	Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α).

Secondary

Measure	Time frame	Description
systemic lupus erythematosus disease activity index (SLEDAI) score.	3 months	Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score.
The safety and tolerability of Coenzyme Q10	3 months	Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026