Docohexanoic Acid in Hemodialysis Patients

September 16, 2020 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Effect of Oral Administration of Docohexanoic Acid on Anemia-inflammation in Hemodialysis Patients. A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
The patients on this arm received usual medical care
Drug: Control-No drug
Patients received usual medical care with no DHA
ACTIVE_COMPARATOR: DHA supplementation
The patients on this arm received DHA supplementation (650 mg DHA/3 times/wk/post-HD session)
Drug: Docohexanoic acid
Patients received 650 mg DHA/3 times/wk/post-HD session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine correction of anemia
Time Frame: 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%.
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%.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (ACTUAL)

September 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHA-HD (188-16)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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