UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060803 |
|---|---|
| Receipt number | R000069563 |
| Scientific Title | Effects of collagen peptide-containing micronutrient supplementation on biochemical indices in hemodialysis patients. |
| Date of disclosure of the study information | 2026/03/04 |
| Last modified on | 2026/03/05 09:29:01 |
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Basic information
Public title
Effects of nutritional supplement drink intake on biochemical indicators in dialysis patients.
Acronym
The effects of nutritional supplements on dialysis patients.
Scientific Title
Effects of collagen peptide-containing micronutrient supplementation on biochemical indices in hemodialysis patients.
Scientific Title:Acronym
Effects of nutritional supplement drink intake on biochemical indicators in hemodialysis patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease (Hemodialysis patients)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemodialysis therapy, due to its therapeutic characteristics, has been noted to potentially remove not only accumulated uremic toxins and excess fluid from the body, but also trace nutrients and vitamins essential for maintaining biological homeostasis. Deficiencies in these nutrients are implicated in impairing the maintenance of normal biological functions and have been suggested to be associated with worsened prognosis.
This study therefore investigates the actual state of nutrient loss associated with dialysis treatment, the effects of supplementation, and its safety by administering a nutritional supplement beverage containing protein, vitamins, and tracing elements to hemodialysis patients and examining changes in biochemical indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood biochemistry test values before and after intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of nutritional supplement drink.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing maintenance hemodialysis with a nutritional status of moderate or better.
2) Patients with no problems in eating or swallowing function who can independently consume the test food.
3) Patients who understand the explanation given by the person in charge regarding participation in this study and are able to obtain consent to participate in this study of their own volition.
Key exclusion criteria
1) Patients for whom obtaining their own expression of intent and consent regarding participation in this study are difficult.
2) Patients with blood test results showing serum albumin levels below 3.0 g/dL.
3) Patients for whom discontinuing consumption of foods that could potentially affect fluctuations in protein and micronutrients due to ingestion of the test food is difficult.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Sumihiko |
| Middle name | |
| Last name | Sato |
Organization
Medical Corporation Credo Sato Clinic
Division name
Department of Nephrology and Dialysis
Zip code
264-0021
Address
2138-1 Wakamatsucho, Wakaba-Ku, Chiba City, Chiba Prefecture
TEL
043-214-3109
ssato@3109jp.com
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Okama |
Organization
Medical Corporation Credo Sato Clinic
Division name
Department of Medical Technology
Zip code
264-0021
Address
2138-1 Wakamatsucho, Wakaba-Ku, Chiba City, Chiba Prefecture
TEL
043-214-3109
Homepage URL
ookama@3109jp.com
Sponsor or person
Institute
Medical Corporation Credo Sato Clinic
Institute
Department
Personal name
Funding Source
Organization
Nutri Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sato Clinic Institutional Review Board
Address
2138-1 Wakamatsucho, Wakaba-Ku, Chiba City, Chiba Prefecture
Tel
043-214-3109
uchida@3109jp.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069563
