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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031935
Receipt No. R000036473
Scientific Title Biochemical assessment and treatment for mental status in children
Date of disclosure of the study information 2018/03/28
Last modified on 2019/06/11

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Basic information
Public title Biochemical assessment and treatment for mental status in children
Acronym Biochemical assessment and treatment for mental status in children
Scientific Title Biochemical assessment and treatment for mental status in children
Scientific Title:Acronym Biochemical assessment and treatment for mental status in children
Region
Japan

Condition
Condition Iron deficiency
Classification by specialty
Hematology and clinical oncology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of sodium ferrous citrate on somatic and psychiatric symptoms of children with iron deficiency

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of efficacy using Clinical Global Impression
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
Medicine
Interventions/Control_1 sodium ferrous citrate 25mg-100mg
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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Children with iron deficiency
Key exclusion criteria Children taking psychotropic
Children wtih serious physical disease (malignancy, infection, endocrine and so on)
Children with psychotic disorder or epilepsy
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Katsunaka
Middle name
Last name Mikami
Organization Tokai University School of Medicine
Division name Department of psychiatry
Zip code 2591193
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL 0463931121
Email mikami@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Katsunaka
Middle name
Last name Mikami
Organization Tokai University School of Medicine
Division name Department of psychiatry
Zip code 2591193
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL 0463931121
Homepage URL
Email mikami@is.icc.u-tokai.ac.jp

Sponsor
Institute Department of psychiatry, Tokai 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
Tel 0463931121
Email tokai-rinsho@ml.tokai-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 28 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
2018 Year 02 Month 20 Day
Date of IRB
2018 Year 02 Month 20 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2019 Year 03 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
2018 Year 03 Month 28 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036473

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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