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

End Stage Renal Disease Clinical Trial

Official title:

Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02581449
• Other study ID #: PHCL31528
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 11, 2015
• Last updated: October 20, 2015
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: October 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• omega-3
dietary supplement

Other:
• empty soft gelatin capsules
empty softgels of matched size, shape and color

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	effect on inflammation via measurement of C- Reactive Protein		four months	Yes
Other	effect on nitric oxide (serum concentration)		four months	Yes
Primary	effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde		four months	Yes
Secondary	effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)		four months	Yes