Renal DialysisNCT05469620
Adaptive Nutrition Therapy in Hemodialysis
A study testing Meal and Education in people with Renal Dialysis, run by Inje University at 1 site in South Korea.
Trial summary
8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Meal and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2021to 28 Feb 2022
- 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
- have been on hemodialysis for over 3 months
Who cannot join
- diagnosed with cancer within 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients
8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.
- Conditions
- Renal Dialysis
- Being tested
- Meal, Education
- Keywords
- nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealDietary supplement
Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.
EducationOther
Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive usual care. |
| Education | Experimental | Receive nutrition education. Receives: Other: Education |
| Meal | Experimental | Receive meal kit. Receives: Dietary Supplement: Meal |
| Education and Meal | Experimental | Receive both nutrition education and meal kit. Receives: Dietary Supplement: Meal; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potassium
Serum potassium level measured from routine blood test.
Measured: 4 weeks
Phosphate
Serum phosphate level measured from routine blood test.
Measured: 4 weeks
Malnutrition
10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)
Measured: 8 weeks
Secondary outcomes (2)
Depression
21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression).
Measured: 8 weeks
Self-Efficacy
10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start6 Oct 2021
- Primary completion26 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies 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
- Factorial
- Model description
- 2 by 2 factorial design, consisting of nutrition education and meal kit prescription.
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Kangnam Sacred Heart Hospital, KangWon National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, Myongji Hospital, Korea Data Agency, Eatmapl, Daejeon Eulji University Medical Center, Seoul National University
- Responsible party
- Principal investigator, Hoseok Koo, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469620
- Sponsor's protocol ID
- DNET_CKD nutrition 1.0
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung MK, Kim DH, Park JI, Lee S, Park HC, Kim K, Kang YS, Ko K, Kim J, Koo H, Kim HJ, Cha JJ, Kwon YE, Kim JH. Adaptive Nutrition Intervention Stabilizes Serum Phosphorus Levels in Hemodialysis Patients: A Multicenter Decentralized Clinical Trial Using Real-World Data. J Ren Nutr. 2024 Jan;34(1):47-57. doi: 10.1053/j.jrn.2023.07.004. Epub 2023 Aug 14.
PubMed 37586668
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05469620
- Acronym / sponsor ID
- DNET_CKD nutrition 1.0
- Conditions
- Renal Dialysis
- Keywords
- nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Hallym University Kangnam Sacred Heart Hospital, KangWon National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, Myongji Hospital, Korea Data Agency, Eatmapl, Daejeon Eulji University Medical Center, Seoul National University
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 26 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Jul 2022 (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.
8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 by 2 factorial design, consisting of nutrition education and meal kit prescription.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive usual care. |
| Education | Experimental | Other: EducationReceive nutrition education. |
| Meal | Experimental | Dietary Supplement: MealReceive meal kit. |
| Education and Meal | Experimental | Dietary Supplement: Meal, Other: EducationReceive both nutrition education and meal kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- have been on hemodialysis for over 3 months
Key exclusion criteria (1 listed)
- diagnosed with cancer within 5 years
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 |
|---|---|---|
| MealEither a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day. | Dietary supplement | Education and Meal, Meal |
| EducationLeaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links. | Other | Education, Education and Meal |
Primary outcome
Potassium
Time frame: 4 weeks
Serum potassium level measured from routine blood test.
Phosphate
Time frame: 4 weeks
Serum phosphate level measured from routine blood test.
Malnutrition
Time frame: 8 weeks
10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)
2 secondary outcomes
Depression
Time frame: 8 weeks
Self-Efficacy
Time frame: 8 weeks
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 22 Jul 2022.
- Derived from this study: PubMed 37586668Chung MK, Kim DH, Park JI, Lee S, Park HC, Kim K, Kang YS, Ko K, Kim J, Koo H, Kim HJ, Cha JJ, Kwon YE, Kim JH. Adaptive Nutrition Intervention Stabilizes Serum Phosphorus Levels in Hemodialysis Patients: A Multicenter Decentralized Clinical Trial Using Real-World Data. J Ren Nutr. 2024 Jan;34(1):47-57. doi: 10.1053/j.jrn.2023.07.004. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal and Education in people with Renal Dialysis, run by Inje University at 1 site in South Korea.
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 1 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Potassium (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05469620, which also lists 1 linked publication.
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 22 Jul 2022.