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OpenTrials
Completed

NCT Number: NCT03125265

DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study

The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to evaluate the association between nutrition and dietary patterns and health outcomes in prevalent adult haemodialysis patients in Europe and South America.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End-stage kidney disease
  • Long-term haemodialysis for at least the previous 90 days
  • 18 years or older
  • Treating team agrees to the patient's involvement in the study
  • Participant willing to provide written and informed consent.-

Exclusion criteria

  • significant neurocognitive disability or medical comorbidity that would preclude them from understanding the dietary questionnaire even if assisted
  • a life expectancy less than 6 months according to their treating physician
  • planned kidney transplantation within 6 months of baseline

Treatment and study plan

dietary intake of omega-3 and omega-6 polyunsaturated fatty acids

Other

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 12 months since baseline dietary evaluation

    Defined as sudden death or death attributed to acute myocardial infarction, pericarditis, atherosclerotic heart disease, cardiomyopathy, cardiac arrhythmia, cardiac arrest, valvular heart disease, pulmonary edema, or congestive cardiac failure

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months since baseline dietary evaluation

  2. Infection-related mortality

    Time frame: 12 months since baseline dietary evaluation

  3. All-cause and cardiovascular related hospitalisation

    Time frame: 12 months since baseline dietary evaluation

Sponsors and collaborators

Lead sponsor

Giovanni Strippoli

Other

Collaborators

  • University of Sydney

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2017
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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