HyperphosphatemiaNCT02755961
Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients
A study testing Dietary education and Education on phosphate binder use in people with Hyperphosphatemia and End-stage Renal Disease, run by Ajou University School of Medicine.
Trial summary
Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, End-stage Renal Disease
- What is being tested?
- Dietary education and Education on phosphate binder use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- End-stage renal disease patients whose dialysis vintage is more than 3 months
Who cannot join
- Patients with liver cirrhosis
- Pregnant patients
- Patients with alimentary tract malabsorption diseases
- History of recent alcohol or drug abuse
- Patients receiving chemotherapy for solid organ tumor
- History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Reducing High-Phosphate Containing Diet Education and Proper Phosphate Binder Intake Education to Serum Phosphate Level Among Maintenance Hemodialysis Patients
Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.
Read the detailed description
Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. Hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. Phosphate is usually obtained by food intake, and it can be removed by hemodialysis. However, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Being tested
- Dietary education, Education on phosphate binder use
- Keywords
- End-stage renal disease, Phosphate binders, Hyperphosphatemia, Dietary education
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary educationBehavioural
Education on phosphate binder useBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention was performed |
| Education group | Experimental | Dietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction. Receives: Behavioral: Dietary education; Behavioral: Education on phosphate binder use |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who reached Ca x P product lower than 55
Measured: 2-3 month
Secondary outcomes (4)
Changes of MMAS-8 score
Measured: 1 month, 2-3 month
Changes of bioequivalent dose of phosphate binder
Measured: 2-3 month
Changes of PG-SGA
Measured: 2-3 month
Amount of change in dietary phosphorus intake
Measured: 2-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Cheol Jeong, Ajou University School of Medicine
- Investigators
- Jong Cheol Jeong, MD, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755961
- Sponsor's protocol ID
- MED-SUR-15-147
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Reducing High-Phosphate Containing Diet Education and Proper Phosphate Binder Intake Education to Serum Phosphate Level Among Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02755961
- Acronym / sponsor ID
- MED-SUR-15-147
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Keywords
- End-stage renal disease, Phosphate binders, Hyperphosphatemia, Dietary education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.
Detailed description
Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. Hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. Phosphate is usually obtained by food intake, and it can be removed by hemodialysis. However, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention was performed |
| Education group | Experimental | Behavioral: Dietary education, Behavioral: Education on phosphate binder useDietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End-stage renal disease patients whose dialysis vintage is more than 3 months
Key exclusion criteria (7 listed)
- Patients with liver cirrhosis
- Pregnant patients
- Patients with alimentary tract malabsorption diseases
- History of recent alcohol or drug abuse
- Patients receiving chemotherapy for solid organ tumor
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 education | Behavioural | Education group |
| Education on phosphate binder use | Behavioural | Education group |
Primary outcome
The proportion of patients who reached Ca x P product lower than 55
Time frame: 2-3 month
4 secondary outcomes
Changes of MMAS-8 score
Time frame: 1 month, 2-3 month
Changes of bioequivalent dose of phosphate binder
Time frame: 2-3 month
Changes of PG-SGA
Time frame: 2-3 month
Amount of change in dietary phosphorus intake
Time frame: 2-3 month
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 29 Apr 2016.
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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.
Jong Cheol Jeong, MD principal investigator
Clinical Assistant Professor
Questions about this trial
What is this clinical trial studying?
A study testing Dietary education and Education on phosphate binder use in people with Hyperphosphatemia and End-stage Renal Disease, run by Ajou University School of Medicine.
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 1 inclusion and 7 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 29 Apr 2016. 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?
The proportion of patients who reached Ca x P product lower than 55 (time frame: 2-3 month). 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 29 Apr 2016.