UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053894 |
|---|---|
| Receipt number | R000061519 |
| Scientific Title | Effect of Carnitine Supplementation Additive to Exercise Therapy in Dialysis Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/22 23:03:42 |
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Basic information
Public title
Effect of Carnitine Supplementation Additive to Exercise Therapy in Dialysis Patients: A Randomized Controlled Trial
Acronym
Effect of Carnitine Supplementation Additive to Exercise Therapy in Dialysis Patients
Scientific Title
Effect of Carnitine Supplementation Additive to Exercise Therapy in Dialysis Patients: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Carnitine Supplementation Additive to Exercise Therapy in Dialysis Patients: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Dialysis patients
Classification by specialty
| Medicine in general | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of 12-week carnitine supplementation additive to exercise training in dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
VO2peak (peak oxygen uptake) assessed by cardiopulmonary test, evaluated 12 weeks after the assignment
Key secondary outcomes
The following parameters at 12 weeks after the assignment:
VE/VCO2 slope, WR (work rate), AT (anaerobic threshold), and CI (chronotropic index) assessed by cardiopulmonary test
Various physical activity levels (including adherence to home exercise therapy) assessed by iAide2
Body composition (including skeletal mass index [SMI]) as assessed by InBody
Specific clinical parameters (nutritional status, anemia, carnitine profile, biomarkers of cardiac function, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Intervention: 12-week carnitine supplementation in addition to exercise therapy
Exercise training includes 3-5 minutes of stretching followed by 10-30 minutes of aerobic exercise, plus 3-5 minutes of stretching afterward thrice-weekly. Exercise intensity is determined by the result of cardiopulmonary test at baseline, and aerobic exercise will be performed with the target of AT level, with rating of perceived exertion (RPE) of 11-13. If undergoing hemodialysis, exercise with an ergometer or similar device between 30 minutes after the start of hemodialysis and the first half of hemodialysis. If not undergoing hemodialysis, use the same home combination of 3-5 minutes of stretching, 10-30 minutes of aerobic exercise, and 3-5 minutes of stretching.
Carnitine supplementation (is covered by health insurance and) is administered to the intervention group only as follows:
Drug used: L-Cartin FF Tablets 250 mg
Dosage and administration: 3.0 g orally per day in 3 divided doses. The dose may be reduced to 1.5 g depending on the patient's condition.
Interventions/Control_2
Control: 12-week exercise therapy only
Exercise therapy will be the same as in the intervention group.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Dialysis outpatients with carnitine deficiency or high risk of carnitine deficiency (free carnitine [FC] < 36 micromol/L) and/or carnitine insufficiency (acylcarnitine [AC]/FC > 0.40)
2) Patients from whom written informed consent was obtained
Key exclusion criteria
1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases.
2) Unstable dialysis patients. Concrete criteria are as follows: patients who undergo dialysis less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L).
3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Uchiyama |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Nephrology
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba, Japan
TEL
+81-476-35-5600
kiyo.0817.piyo@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Uchiyama |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Nephrology
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba, Japan
TEL
+81-476-35-5600
Homepage URL
kiyo.0817.piyo@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Narita Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board for Clinical Research of International University of Health and Welfare
Address
852 Hatakeda, Narita, Chiba, Japan
Tel
+81-476-35-5613
rinri_md@iuhw.ac.jp
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
国際医療福祉大学成田病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061519
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| Registered date | File name |
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