UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011432 |
|---|---|
| Receipt number | R000013383 |
| Scientific Title | Investigation of effects of vitamin C on fatigue. |
| Date of disclosure of the study information | 2013/08/17 |
| Last modified on | 2019/02/15 11:24:35 |
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Basic information
Public title
Investigation of effects of vitamin C on fatigue.
Acronym
Investigation of effects of vitamin C on fatigue.
Scientific Title
Investigation of effects of vitamin C on fatigue.
Scientific Title:Acronym
Investigation of effects of vitamin C on fatigue.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate effects of vitamin C on fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of objective fatigue symptoms, fatigue related factors in blood and saliva samples.
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 | Maneuver |
Interventions/Control_1
Taking vitamin C, drawing blood, questionnaires and medical interviews
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People able to take vitamin C 2000 mg/day for four weeks at Otemachi Sakura Clinic in Toyosu.
Key exclusion criteria
Lack of ability to consent, severe physical illness, people judged not suitable by doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
kkondo@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Virus Ikagaku Kenkyusho Inc.
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
大手町さくらクリニックin豊洲(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 14 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
