Skip to main content
OpenTrials
Completed

NCT Number: NCT04536636

Docohexanoic Acid in Hemodialysis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docohexanoic acid

Drug

Patients received 650 mg DHA/3 times/wk/post-HD session

Control-No drug

Drug

Patients received usual medical care with no DHA

Primary outcomes

  1. 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%.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 2, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.