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

NCT02581449 | Unknown Phase 2

• 1 other identifier: PHCL31528
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease

Keywords

omega-3 fatty acids; hemodialysis; oxidative stress; dyslipidemia

Outcome Measures

Primary Outcomes (1)

• effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde

  four months

Secondary Outcomes (1)

• effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)

  four months

Other Outcomes (2)

• effect on inflammation via measurement of C- Reactive Protein

  four months

• effect on nitric oxide (serum concentration)

  four months

Study Arms (2)

omega-3 group

EXPERIMENTAL

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

Dietary Supplement: omega-3

placebo group

PLACEBO COMPARATOR

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

Other: empty soft gelatin capsules

Interventions

omega-3 DIETARY_SUPPLEMENT

dietary supplement

Also known as: NOW foods omega-3 softgels

omega-3 group

empty soft gelatin capsules OTHER

empty softgels of matched size, shape and color

placebo group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Dyslipidemias

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ain Shams

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Study Record Dates

• First Submitted: October 11, 2015
• First Posted: October 21, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 21, 2015

Record last verified: 2015-10