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Docohexanoic Acid in Hemodialysis Patients

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Docohexanoic acid
Control-No drug
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control

DHA supplementation

Arm Description

The patients on this arm received usual medical care

The patients on this arm received DHA supplementation (650 mg DHA/3 times/wk/post-HD session)

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
September 16, 2020
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT04536636
Brief Title
Docohexanoic Acid in Hemodialysis Patients
Official Title
Effect of Oral Administration of Docohexanoic Acid on Anemia-inflammation in Hemodialysis Patients. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The patients on this arm received usual medical care
Arm Title
DHA supplementation
Arm Type
Active Comparator
Arm Description
The patients on this arm received DHA supplementation (650 mg DHA/3 times/wk/post-HD session)
Intervention Type
Drug
Intervention Name(s)
Docohexanoic acid
Intervention Description
Patients received 650 mg DHA/3 times/wk/post-HD session
Intervention Type
Drug
Intervention Name(s)
Control-No drug
Intervention Description
Patients received usual medical care with no DHA
Primary Outcome Measure Information:
Title
Determine correction of anemia
Description
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%.
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%.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33487255
Citation
Ruperto M, Rodriguez-Mendiola N, Diaz-Dominguez M, Gimenez-Moyano S, Garcia-Bermejo ML, Fernandez-Lucas M. Effect of oral administration of docohexanoic acid on anemia and inflammation in hemodialysis patients: A randomized controlled clinical trial. Clin Nutr ESPEN. 2021 Feb;41:129-135. doi: 10.1016/j.clnesp.2020.12.004. Epub 2020 Dec 31.
Results Reference
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Docohexanoic Acid in Hemodialysis Patients

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