Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

Ain Shams University

Status: Completed

Conditions: Hemodialysis

Treatments: Other: Placebo; Dietary Supplement: Coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT05170893

ACUC-FP-ASU RHDIRB2020110301

Details and patient eligibility

About

All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.

Enrollment: 36 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients with ages between 2 to 18 years old.
• Undergoing regular hemodialysis for at least 6 months.

Exclusion criteria

• Patients who weigh less than 10 kg.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Oral Coenzyme Q10 capsules daily for 12 weeks.

Treatment:

Dietary Supplement: Coenzyme Q10

Control group

Placebo Comparator group

Description:

Oral capsules similar to the intervention daily for 12 weeks.

Treatment:

Other: Placebo