UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005771 |
|---|---|
| Receipt number | R000006820 |
| Scientific Title | Studies on in vivo effects of drinking a water product supplemented with platinum nanocolloid on oxidative stress in humans |
| Date of disclosure of the study information | 2011/11/30 |
| Last modified on | 2011/10/17 11:55:03 |
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Basic information
Public title
Studies on in vivo effects of drinking a water product supplemented with platinum nanocolloid on oxidative stress in humans
Acronym
Effects of drinking platinum nanocolloid-containing water in humans
Scientific Title
Studies on in vivo effects of drinking a water product supplemented with platinum nanocolloid on oxidative stress in humans
Scientific Title:Acronym
Effects of drinking platinum nanocolloid-containing water in humans
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
detection of reduction in oxidative stress and changes in hepatic and renal functions in subjects who ingested a water product supplemented with platinum nanocolloid as an antioxidant additive.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the levels of serum LPO, AST, ALT and minerals including Pt and urine 8-OHdG, alfa-1 microglobilin and minerals including Pt in subjects before and after ingestion of Pt nanocollid-containing water (500ml/day) for 1 week
Key secondary outcomes
the levels of same blood and urine components as in same subjects as above, after 1-week washing-out period and 1-week following drinking period of natural water as the control drink
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 6ug (in 500ml) per day of platinum nanocolooid-containing water (PtW) and the control drink (natural water) for 1 week, respectively, with the interval period (1-week) for washing-out Pt nanocolloid
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
| 21 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy students
Key exclusion criteria
persons with hepatic or renal dysfunction and females in menstruation period
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hiraoka |
Organization
Kyorin University
Division name
Faculty of Health Sciences
Zip code
Address
476 Miyashita-cho, hachioji-shi, Tokyo, Japan
TEL
042-691-0011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi hiraoka |
Organization
Fculty of Health Sciences, Kyorin University
Division name
Laboratory of Cytogenetics
Zip code
Address
476 Miyashita-cho, Hachioji-shi, Tokyo, Japan
TEL
042-691-0011
Homepage URL
hiraokaa@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
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
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
| 2011 | Year | 11 | Month | 30 | 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
No significant change was found in the levels of blood and urine oxidative stress markers, although the mean values were lowest immediately after drinking period for Pt nanocolloid-containing water (PtW). The serum ALT activity was significantly raised immediately after drinking period for PtW, and then reduced to the original level through the periods for washing-out Pt nanocolloid and drinking control water.
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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2011 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006820
