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

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: End Stage Renal Disease

Treatments: Dietary Supplement: omega-3; Other: empty soft gelatin capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02581449

PHCL31528

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

omega-3 group

Experimental group

Description:

omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months

Treatment:

Dietary Supplement: omega-3

placebo group

Placebo Comparator group

Description:

empty soft gelatin capsules with matched size, color and shape once daily for four months

Treatment:

Other: empty soft gelatin capsules