Diet HabitNCT03125265
DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
An observational study of Diet Habit and End Stage Renal Disease, run by Giovanni Strippoli.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet Habit, End Stage Renal Disease
- What is being tested?
- dietary intake of omega-3 and omega-6 polyunsaturated fatty acids
- How many people
- 9,757 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2014to 31 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: dialysis clinics administered by a single dialysis provider
Who may be able to join
- 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.-
Who cannot join
- 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
About this 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.
- Conditions
- Diet Habit, End Stage Renal Disease
- Being tested
- dietary intake of omega-3 and omega-6 polyunsaturated fatty acids
- Keywords
- nutrition, hemodialysis, mortality, omega 3
- Medical subject headings
- Feeding Behavior, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intake of omega-3 and omega-6 polyunsaturated fatty acidsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
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
Measured: 12 months since baseline dietary evaluation
Secondary outcomes (3)
All-cause mortality
Measured: 12 months since baseline dietary evaluation
Infection-related mortality
Measured: 12 months since baseline dietary evaluation
All-cause and cardiovascular related hospitalisation
Measured: 12 months since baseline dietary evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start5 Jan 2014
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giovanni Strippoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Sponsor-investigator, Giovanni Strippoli, University of Bari
- Investigators
- Giovanni FM Strippoli, MD, PhD, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125265
- Sponsor's protocol ID
- DIET-HD study
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study
- ClinicalTrials.gov ID
- NCT03125265
- Acronym / sponsor ID
- DIET-HD study
- Conditions
- Diet Habit, End Stage Renal Disease
- Keywords
- nutrition, hemodialysis, mortality, omega 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,757 participants (actual)
- Lead sponsor
- Giovanni StrippoliUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 5 Jan 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- dialysis clinics administered by a single dialysis provider
Key inclusion criteria (5 listed)
- 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.-
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary intake of omega-3 and omega-6 polyunsaturated fatty acids | Other | – |
Primary outcome
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
3 secondary outcomes
All-cause mortality
Time frame: 12 months since baseline dietary evaluation
Infection-related mortality
Time frame: 12 months since baseline dietary evaluation
All-cause and cardiovascular related hospitalisation
Time frame: 12 months since baseline dietary evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni FM Strippoli, MD, PhD
University of Bari
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and End Stage Renal Disease, run by Giovanni Strippoli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 12 months since baseline dietary evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.