Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

Phase 2

• Conditions: End Stage Renal Disease
• Interventions: Other: empty soft gelatin capsules; Dietary Supplement: omega-3

• Registration Number: NCT02581449
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients between 8 and 18 years old
• Patients treated with HD for at least 6 months

Exclusion Criteria

• Patients with malignancy and active inflammatory disease.
• Patients who received vitamin E or any antioxidant treatment during the past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	empty soft gelatin capsules	empty soft gelatin capsules with matched size, color and shape once daily for four months
omega-3 group	omega-3	omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months

Primary Outcome Measures

Name	Time	Method
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde	four months

Secondary Outcome Measures

Name	Time	Method
effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)	four months