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

Ain Shams University

Status and phase: Enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT07096557

RHDIRB2020110301 REC #272

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy and safety of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:

• What the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?
• Does it have beneficial effect on disease activity through assessment of 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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts 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.
3. No enrollment in any other clinical trial.
4. Judged by the physician to be physically stable.

Exclusion criteria

1. Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine or vitamin C that can enhance the effect of CoQ10.
2. Patients with very severe active SLE that might threaten vital organs.
3. Patients with chronic infections, severe and recurrent infections whether bacterial, viral, or fungal infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Coenzyme Q10 group

Experimental group

Description:

Group 1 (Coenzyme Q10 group): consists of 30 patients who will receive one capsule containing 100 mg Coenzyme Q10 once daily for 12 weeks, "Coenzyme Q10 Forte® ".

Treatment:

Drug: Coenzyme Q10

Control group

No Intervention group

Description:

Group 2 (Control group): consists of 30 patients who will not receive the intervention.