Declination of Glomerular Infiltration Rate in Chronic Kidney Disease PopulationNCT02519894
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
A study testing Dietary Scanning Calculator in people with Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population, run by PANTHITA SORNHIRAN.
Trial summary
Introduction : Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
- What is being tested?
- Dietary Scanning Calculator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
- Microalbuminuria
- Any blood pressure level
Who cannot join
- Salt - losing conditions
- Hyponatremia (Na < 135 mg/dL) or Hypernatremia (Na > 145 mg/dL)
- Bilateral renal artery stenosis
- Severe comorbid disease or life expectancy <1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
- Immunosuppressant used
About this study
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
Read more
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
- Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)
- Blood pressure difference
- Proportions of patients with BP reached the target (130/80 mmHg)
- Number of anti-hypertensive drugs use to achieve BP target
- Urine albumin/creatinine ratio
- Major Adverse Cardiac Events (MACE)
- Cardio-ankle vascular index (CAVI)
- ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
- Being tested
- Dietary Scanning Calculator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Scanning CalculatorBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator Receives: Behavioral: Dietary Scanning Calculator |
| Controlled group | Placebo comparator | Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The declination of glomerular infiltration rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Declination of Glomerular Infiltration Rate in Chronic Kidney Disease PopulationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PANTHITA SORNHIRAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PANTHITA SORNHIRAN, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519894
- Sponsor's protocol ID
- Ramathibodi Hospital
- Status last verified
- Aug 2015
- First submitted
- 9 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02519894
- Acronym / sponsor ID
- Ramathibodi Hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PANTHITA SORNHIRANUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Aug 2015 (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.
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
- Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)
- Blood pressure difference
- Proportions of patients with BP reached the target (130/80 mmHg)
- Number of anti-hypertensive drugs use to achieve BP target
- Urine albumin/creatinine ratio
- Major Adverse Cardiac Events (MACE)
- Cardio-ankle vascular index (CAVI)
- ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dietary Scanning CalculatorIntensive low sodium education and immediate sodium intake feedback by dietary scanning calculator |
| Controlled group | Placebo comparator | –Standard education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
- Microalbuminuria
- Any blood pressure level
Key exclusion criteria (5 listed)
- Salt - losing conditions
- Hyponatremia (Na < 135 mg/dL) or Hypernatremia (Na > 145 mg/dL)
- Bilateral renal artery stenosis
- Severe comorbid disease or life expectancy <1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
- Immunosuppressant used
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 Scanning Calculator | Behavioural | Intervention group |
Primary outcome
The declination of glomerular infiltration rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Scanning Calculator in people with Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population, run by PANTHITA SORNHIRAN.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 declination of glomerular infiltration rate (time frame: one year). 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 11 Aug 2015.