Clinical trial NCT04536636: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Determine correction of anemia
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
References:
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.