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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016738
Receipt No. 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

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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)
Email 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
Email yashiohp@nifty.com

Sponsor
Institute Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019392

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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