ClinicalTrials.gg
CompletedNCT03396328Updated Sep 29, 2020

Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria

An interventional study of conventional low salt education and Intensive low salt dietary education by smartphone application in Albuminuria, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

Albuminuria is a known risk factor for cardiovascular disease (CVD), chronic kidney disease (CKD) progression, all cause mortality. Inhibition of the renin-angiotension-aldosterone system (RAAS) plays an important role in the reduction of albuminuria and preservation of renal function in patients with CKD and it is known that the daily intakes of sodium have a significant effect on the activity of RAAS. Dietary sodium restriction has been shown to enhances the blood pressure, albuminuria, and renal function preservation. Furthermore, recent study has shown that intensive low-salt dietary education reduces albuminuria in patients with CKD. The average sodium intake of Koreans is 4,791 mg/d, which is higher than other countries. It is difficult for medical staff in Korea to invest enough time in low salt diet.

Recently, the development of health-related applications (apps) has been carried out worldwidely, and researches on lifestyle improvement using apps have been actively studied. However, there is no research yet on whether intensive education using an apps can affect lifestyle habits and thus changes in actual new features. Smartphone apps may provide an alternative to resource-intensive low salt diet-education. Therefore, this study aims to investigate the effect of intensive low salt diet training on the changes of albuminuria using application.

Read the detailed description

This is an pen-label, case-control, randomized clinical trial.

  • Run-in period (8 weeks) : before 8 weeks of study initiation, all of the patients have to stop all RAAS blockers or diuretics and switch to antihypertensive agents of other categories such as calcium channel blockers.
  • 0-8 weeks : After run-in period, the patients complete laboratory examination and a dish frequency questionnaire. From 0 weeks, all participants will be prescribed valsartan 80mg per day until the end of study.
  • 8-16 weeks : After 8 weeks, the patients will be randomly assigned to receive an low-salt dietary intervention after second laboratory examination.

Usual education : Conventional education at an outpatient clinic Intensive education : Low salt diet education through Smartphone app

The patients in the conventional education group will receive routine CKD education once at an outpatient clinic. Otherwise, the patients in the intensive education group will be trained low salt diet through smartphone app.

02

Conditions studied

  • Albuminuria

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03

In context

Albuminuria

142 studies on the registry are indexed under Albuminuria; 24 are open to participants now.

This study's enrollment of 108 is above the median of 69 across 115 interventional studies indexed under Albuminuria.

Browse Albuminuria studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age : 19-65
  • Underlying hypertension or antihypertensive medication , or Systolic blood pressure ≧ 140 mmHg or Diastolic blood pressure ≧ 90
  • Modification of Diet in Renal Disease study () eGFR ≧ 30 ml/min per 1.73m2
  • Random urine albumin-to-creatinine ratio ≧ 30 mg/g
  • Smartphone ownership

Exclusion criteria

Exclusion Criteria:

  • Age under 18 or over 66
  • Uncontrolled hypertension (BP>160/110 mmHg)
  • Pregnancy within 6 months
  • Serum potasium > 5.5 mEq/L
  • a diagnosis of CVD (cerebral infarction, hemorrhagic infarction, acute myocardial infarction or unstable angina, coronary angioplasty, or coronary artery bypass surgery) within the last 6 months
  • to angiotensin II receptor blocker
  • less than 6 months
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Conventional education

    Behavioral: conventional low salt education

  • Experimental
    Low salt dietary education by smartphone application

    Behavioral: Intensive low salt dietary education by smartphone application

Interventions

  • Behavioralconventional low salt education

    conventional low salt education

  • BehavioralIntensive low salt dietary education by smartphone application

    Participants are provided with information on food and recipe, which allows them to record daily meals in their applications. Through the mobile application, the participants receive information on daily salt intake. Based on this information, the clinical nutritionist coach sets a goal for low salt diet and provides feedback to the patients through the mobile application. The clinical nutritionist coach checks the activity of the user more than twice a week and sends in-app messages to maintain compliance.

06

What researchers measure

Primary outcomes

  1. Decrements of 24-hour urine albumin levels

    Decrements of 24-hour urine albumin levels 12 weeks after low salt diet education

    Time frame: 12 weeks after low salt diet education start

Secondary outcomes

  1. Decrements of 24-hour urine sodium

    Time frame: 12 weeks after low salt diet education start

  2. Change of blood pressure with a sphygmomanometer

    Time frame: 12 weeks after low salt diet education start

07

Study locations

1 site
  • Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in May 2020, 24 months.

Of 22 interventional studies with no phase under Albuminuria, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 48. This study's 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2018
First posted
Jan 10, 2018
StartActual
May 10, 2018
Primary completionActual
May 12, 2020
CompletionActual
May 12, 2020
Last update
Sep 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03396328
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
May 10, 2018
Primary completion
May 12, 2020
Completion
May 12, 2020
Last update
Sep 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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