Overview

This trial is active, not recruiting.

Condition end stage renal disease
Treatments omega-3, empty soft gelatin capsules
Phase phase 2
Sponsor Ain Shams University
Start date September 2015
End date January 2016
Trial size 50 participants
Trial identifier NCT02581449, PHCL31528

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months
omega-3 NOW foods omega-3 softgels
dietary supplement
(Placebo Comparator)
empty soft gelatin capsules with matched size, color and shape once daily for four months
empty soft gelatin capsules
empty softgels of matched size, shape and color

Primary Outcomes

Measure
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
time frame: four months

Secondary Outcomes

Measure
effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
time frame: four months

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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.

Additional Information

Official title Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
Principal investigator Ain Shams
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ain Shams University.