Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2018-06-01
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
The patients on this arm received usual medical care
Control-No drug
Patients received usual medical care with no DHA
DHA supplementation
The patients on this arm received DHA supplementation (650 mg DHA/3 times/wk/post-HD session)
Docohexanoic acid
Patients received 650 mg DHA/3 times/wk/post-HD session
Interventions
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Docohexanoic acid
Patients received 650 mg DHA/3 times/wk/post-HD session
Control-No drug
Patients received usual medical care with no DHA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Locations
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Hospital Ramón y Cajal
Madrid, , Spain
Countries
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References
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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.
Other Identifiers
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DHA-HD (188-16)
Identifier Type: -
Identifier Source: org_study_id
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