UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001055 |
|---|---|
| Receipt number | R000001266 |
| Scientific Title | Efficacy of the nutrients supplement "AMP01" for the fatigue of the hemodialysis patients |
| Date of disclosure of the study information | 2008/03/01 |
| Last modified on | 2008/10/14 10:36:33 |
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Basic information
Public title
Efficacy of the nutrients supplement "AMP01" for the fatigue of the hemodialysis patients
Acronym
Efficacy of "AMP01" for the fatigue of the hemodialysis patients
Scientific Title
Efficacy of the nutrients supplement "AMP01" for the fatigue of the hemodialysis patients
Scientific Title:Acronym
Efficacy of "AMP01" for the fatigue of the hemodialysis patients
Region
| Japan |
Condition
Condition
Dialysis Patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an efficacy of supplementation of nutrients with "AMP01" for the fatigue of hemodialysis patients by a randomize double-blind placebo-controlled study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Acceleration plethysmogram, fatigue markers (alpha-MSH, ACTH, cortisol, HHV6, 7), questionnaires for acute and chronic fatigue, questionnaires for QOL (KDQOL-SF).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One bottle (50 ml) of the nutrients supplement "AMP01" is to be administered three times a week just after hemodialysis sessions for 12 weeks.
The test food is lightly yellow drink containing carnitine 500mg, CoQ10 30mg, oligosaccharide 5g, zinc 8mg, vitamin B1 10mg, B2 1.8mg, niacin 15mg, B6 10mg, B12 30microg, folic acid 500microg, vitamin C 60mg.
Interventions/Control_2
One bottle (50 ml) of placebo is to be administered three times a week just after hemodialysis sessions for 12 weeks
The placebo is drink which appearance and flavor are the same as the test food.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are equal or more than 30-year-old and less than 70 year-old at the time of getting the Informed consent
(2) Patients undergoing regular afternoon or night hemodialysis
(3) Hemodialysis duration is more than one year
(4) Patients who receive hemodialysis three times a week
(5) Patients who are capable of understanding the study, and those who can give written informed consents
(6) Patients who can adhere instructions
Key exclusion criteria
(1) Patients who are taking nutrients supplements. If the patients can stop taking the supplements two weeks before the study, the patients do not meet exclusion criteria.
(2) Patients who receive vitamin compound (except Vitamin D) for treatment, or take OTC drugs for vitamine supplementation. If the patients can stop the treatment two weeks before the study, the patients do not meet exclusion criteria.
(3) During the pregnancy or nursing , or patients to be pregnant during the study period
(4) patients who participated in other clinical trials for food or drug within the past three months
(5)Patients with allergy against constituents of the supplement
(6) Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Nishizawa |
Organization
Osaka City University Medical School
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3 Asahi-cho, Abeno-ku, Osaka 545-8585
TEL
06-6645-3806
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisako Fujii |
Organization
Osaka City University Hospital
Division name
Center for Drug & Food Clinical Evaluation
Zip code
Address
6th floor Abeno Medix, 1-2-7 Asahi-cho, Abeno-ku, Osaka 545-0051
TEL
06-6645-3443
Homepage URL
hfujii@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI KURARAY MEDICAL 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
Address
Tel
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
| 2008 | Year | 03 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 26 | Day |
Last modified on
| 2008 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001266
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