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Recruitment status Completed
Unique ID issued by UMIN UMIN000005771
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email hiraokaa@ks.kyorin-u.ac.jp

Sponsor
Institute Faculty of Health Sciences, Kyorin University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006820


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