Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125265
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Giovanni Strippoli, University of Bari

Brief Summary:
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.

Condition or disease Intervention/treatment
Diet Habit End Stage Renal Disease Other: dietary intake of omega-3 and omega-6 polyunsaturated fatty acids

Layout table for study information
Study Type : Observational
Actual Enrollment : 9757 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
Actual Study Start Date : January 5, 2014
Actual Primary Completion Date : January 31, 2016
Actual Study Completion Date : January 31, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dialysis clinics administered by a single dialysis provider
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125265


Sponsors and Collaborators
Giovanni Strippoli
University of Sydney
Investigators
Layout table for investigator information
OverallOfficial: Giovanni FM Strippoli, MD, PhD University of Bari, Italy
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Giovanni Strippoli, Associate Professor, University of Bari
ClinicalTrials.gov Identifier: NCT03125265    
Other Study ID Numbers: DIET-HD study
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giovanni Strippoli, University of Bari:
nutrition
hemodialysis
mortality
omega 3
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency