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

April 20, 2017 updated by: Giovanni Strippoli
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

dialysis clinics administered by a single dialysis provider

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months since baseline dietary evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 12 months since baseline dietary evaluation
12 months since baseline dietary evaluation
Infection-related mortality
Time Frame: 12 months since baseline dietary evaluation
12 months since baseline dietary evaluation
All-cause and cardiovascular related hospitalisation
Time Frame: 12 months since baseline dietary evaluation
12 months since baseline dietary evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giovanni Strippoli

Collaborators

University of Sydney

Investigators

  • Giovanni FM Strippoli, MD, PhD, University of Bari, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2014

Primary Completion (ACTUAL)

January 31, 2016

Study Completion (ACTUAL)

January 31, 2016

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIET-HD study

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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