UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031935 |
|---|---|
| Receipt number | 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 13:27:22 |
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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
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
mikami@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Department of psychiatry, Tokai 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036473
