Docohexanoic Acid in Hemodialysis Patients

NCT04536636 | Completed

• 1 other identifier: DHA-HD (188-16)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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%.

Study Arms (2)

Control

ACTIVE COMPARATOR

The patients on this arm received usual medical care

Drug: Control-No drug

DHA supplementation

ACTIVE COMPARATOR

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

Drug: Docohexanoic acid

Interventions

Docohexanoic acid DRUG

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

DHA supplementation

Control-No drug DRUG

Patients received usual medical care with no DHA

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• 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.

  PMID: 33487255 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 2, 2020
• Study Start: June 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 17, 2020

Record last verified: 2020-08

Locations

ES (1)