Docohexanoic Acid in Hemodialysis Patients

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536636
• Other study ID #: DHA-HD (188-16)
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2020
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• Docohexanoic acid
Patients received 650 mg DHA/3 times/wk/post-HD session
• Control-No drug
Patients received usual medical care with no DHA

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.