UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016738 |
|---|---|
| Receipt number | R000019392 |
| Scientific Title | Zinc L-carnosine complex polaprezinc for pica and polydipsia |
| Date of disclosure of the study information | 2015/03/08 |
| Last modified on | 2019/06/23 09:29:09 |
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Basic information
Public title
Zinc L-carnosine complex polaprezinc for pica and polydipsia
Acronym
Zinc L-carnosine complex polaprezinc for pica and polydipsia
Scientific Title
Zinc L-carnosine complex polaprezinc for pica and polydipsia
Scientific Title:Acronym
Zinc L-carnosine complex polaprezinc for pica and polydipsia
Region
| Japan |
Condition
Condition
Pica and polydipsia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of zinc L-carnosine complex polaprezinc in pica patients with or without polydipsia
To examine the changes in serum concentrations of brain-derived neurotrophic factor (BDNF) and mature BDNF before and after polaprezinc treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of pica
Key secondary outcomes
Severity of polydipsia assessed by diurnal weight gain and blood concentration of sodium
Serum concentrations of BDNF and mature BDNF
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Polaprezinc 75 or 150 mg/day per os for 24 weeks.
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
1) At least 20 years of age
2) Pica for 1 month or more according to DSM-V
3) Written informed consent from patients and their legal guardians prior to study entry
Key exclusion criteria
1) Malignant tumor
2) Chronic renal failure (estimated glomerular filtration rate, eGFR <45)
3) Other severe diseases
4) Terminal phase of an illness
5) History of taking polaprezinc or other zinc supplementation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Sakae |
Organization
The Jikei University School of Medicine
Division name
Department of Public Health and Environmental Medicine
Zip code
105-8461
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111(ext.2266)
yashiohp@nifty.com
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Sakae |
Organization
Keieikai Yashio Hospital
Division name
Department of psychiatry
Zip code
340-0802
Address
1089 Tsurugasone, Yashio-shi, Saitama 340-0802, Japan
TEL
048-996-3034
Homepage URL
yashiohp@nifty.com
Sponsor or person
Institute
Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keieikai Yashio Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Jikei University School of Medicine
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.ac.jp
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
医療法人慶榮会 八潮病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 08 | 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
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 08 | Day |
Last modified on
| 2019 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019392
