UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004774 |
|---|---|
| Receipt number | R000005685 |
| Scientific Title | Individual difference of folate metabolism caused by genetic polymorphisms and its improvement by a folate-fortified food (folic acid fortified bread). |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2010/12/22 10:52:08 |
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Basic information
Public title
Individual difference of folate metabolism caused by genetic polymorphisms and its improvement by a folate-fortified food (folic acid fortified bread).
Acronym
Improvement of mutants of folate metabolism by folic acid-fortified bread.
Scientific Title
Individual difference of folate metabolism caused by genetic polymorphisms and its improvement by a folate-fortified food (folic acid fortified bread).
Scientific Title:Acronym
Improvement of mutants of folate metabolism by folic acid-fortified bread.
Region
| Japan |
Condition
Condition
depressive state
Classification by specialty
| Medicine in general | Neurology | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Reduction of depression score of individuals with depression-susceptible genetic polymorphism by folic acid supplementation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
serum folate, serum homocysteine and CES-D depression score.
Key secondary outcomes
Intake of all nutrients, general blood biochemistry
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Gene | Food | Behavior,custom |
Interventions/Control_1
folic acid-fortified bread intake group
Interventions/Control_2
control bread intake group
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy Japanese women
Key exclusion criteria
patients, supplement taker, drug taker.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Kagawa |
Organization
Kagawa Nutrition University
Division name
Faculty of Nutrition
Zip code
Address
3-9-21 Chiyoda, Sakado city, Saitama, Japan 350-0288
TEL
049-282-3618
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Kagawa |
Organization
Kagawa Nutrition University
Division name
Faculty of Nutrition
Zip code
Address
3-9-21 Chiyoda, Sakado City, Saitama Japan 350-0288
TEL
049-282-3618
Homepage URL
kagawa@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Nutrition University
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
Address
Tel
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
女子栄養大学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 31 | 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
Supplementation of folic acid was effective in reducing depression scores in Japanese women with depression-related polymorphisms.
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
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2010 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005685
