Docohexanoic Acid in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: Control-No drug; Drug: Docohexanoic acid

• Registration Number: NCT04536636
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

Docohexanoic acid (DHA), a dietary n-3 polyunsaturated fatty-acid omega-3 (n-3, PUFA), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (HD) patients. This clinical trial aimed to analyze whether DHA supplementation was a modulator of erythropoietin (EPO) response and inflammation in hemodialysis (HD) patients.

Detailed Description

Background. Docohexanoic acid (DHA), a dietary n-3 polyunsaturated fatty-acid omega-3 (n-3, PUFA), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (HD) patients. This clinical trial aimed to analyze whether DHA supplementation was a modulator of erythropoietin (EPO) response and inflammation in hemodialysis (HD) patients.

Methods. In single-blind, controlled clinical trial, 52 HD patients were randomized to either DHA supplementation (650 mg DHA/3 times/wk/post-HD session) or controls (usual medical-care) for 8-weeks. Clinical data by collecting hemoglobin concentration (Hb), weekly dose of EPO, and erythropoietin resistance index (ERI). The inflammatory response was measured using serum C-reactive protein (s-CRP) and plasma homocysteine (tHcy) at baseline (T0) and post-intervention (T1). miR-146a array was used as an inflammatory biomarker. Post-intervention measures were analyzed at 4-weeks intervals and adjusted by baseline in a linear regression.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-02
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• age over 18 years
• chronic stabilized HD treatment for at least 3 months with functional vascular access (arteriovenous fistula or permanent catheter)
• equilibrated Kt/V urea (eKt/V)higher than 1.2
• informed consent form signed

Exclusion Criteria

• exposure to corticosteroids and anti-inflammatory drugs or hospital admissions in last 3 months
• were with ongoing active illnesses, wasting, connective tissue disease, metastatic cancer or malignancy, HIV, uncontrolled chronic hepatic disease or transplantation prior to the start of the study.
• Patients with known hypersensitivity to any of fish intolerance or allergy, history of gastrointestinal bleeding, patients already receiving chronic anticoagulation therapy (antiplatelet agents or warfarin), and patients with terminal or life-threatening disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control-No drug	The patients on this arm received usual medical care
DHA supplementation	Docohexanoic acid	The patients on this arm received DHA supplementation (650 mg DHA/3 times/wk/post-HD session)

Primary Outcome Measures

Name	Time	Method
Determine correction of anemia	Determine correction of anemia measured by erythropoiesis-resistance index (ERI) to detect a difference of 10 units of response between groups at 8 weeks follow-up, with a SD of 10 and a power higher than 80%.	Determine correction of anemia measured by erythropoiesis-resistance index (ERI) to detect a difference of 10 units of response between groups at 8 weeks follow-up, with a SD of 10 and a power higher than 80%.

Trial Locations

Locations (1)

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain