Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients

NCT ID: NCT01509027

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education by DVD and dietician

Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican

Group Type ACTIVE_COMPARATOR

Education by DVD and dietician

Intervention Type BEHAVIORAL

Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican

Education by unpersonalised DVD

Information on detrimental consequences of hyperphosphatemia is presented on DVD

Group Type ACTIVE_COMPARATOR

education by DVD

Intervention Type BEHAVIORAL

Information on detrimental conseqences of hyperphosphatemia is presented on DVD

Standard Care

standard care

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

standard care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

education by DVD

Information on detrimental conseqences of hyperphosphatemia is presented on DVD

Intervention Type BEHAVIORAL

Standard care

standard care

Intervention Type BEHAVIORAL

Education by DVD and dietician

Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* prevalent (\>3months) hemodialysis patients
* aged \> 18 years
* informed consent

Exclusion Criteria

* decreased consciousness
* unstable
* medical contraindication for phosphorus restricted diet or phsophate binder therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pieter Evenepoel, MD

Role: CONTACT

003216344580

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B322201112895

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dialysis Geriatric Care Model
NCT05793138 ENROLLING_BY_INVITATION NA
Peer Support In Dialysis
NCT05400720 COMPLETED NA