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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001055
Receipt No. 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

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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
Email

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
Email hfujii@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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