UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012585 |
|---|---|
| Receipt number | R000014561 |
| Scientific Title | Safety of dietary supplements including n-3 PUFA (Imark S®) for the maintenance of remission in patients with Crohn's disease: A pilot study. |
| Date of disclosure of the study information | 2014/01/10 |
| Last modified on | 2015/11/26 11:30:23 |
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Basic information
Public title
Safety of dietary supplements including n-3 PUFA (Imark S®) for the maintenance of remission in patients with Crohn's disease: A pilot study.
Acronym
Safety of dietary supplements including n-3 PUFA for CD.
Scientific Title
Safety of dietary supplements including n-3 PUFA (Imark S®) for the maintenance of remission in patients with Crohn's disease: A pilot study.
Scientific Title:Acronym
Safety of dietary supplements including n-3 PUFA for CD.
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of liquid supplements including n-3 PUFA(Nippon Suisan Kaisha Ltd. "Imark S®") for remission patients with Crohn's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety study (Blood test indicators, inflammatory cytokine, CDAI)
Key secondary outcomes
Safety check depending on the number of intake.(100ml X 1 or 2 bottle)
Efficacy check of maintenance for remission.(Using CDAI score)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
After 3 month intervention with Imark S supplements, to compare the data before ingestion with after each months intervention.
1 month(30 days): 1 bottle of ingestion/ a day
2 month(30 days): No ingestion
3 month(30 days): 2 bottles of ingestion/ a day
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) Patients diagnosed with Crohn's diseases.
2) Patients expected over 3 month-survival from the first day of this study.
3) Patients who can orally ingestion.
4) Patients whose condition are in remission
5) Patients who are obtained with the prior written consent.
Key exclusion criteria
1) Patients with the following diseases.
(cirrhosis, chronic renal failure, diabetes with insulin therapy and so on)
2) Patients with steroid treatment
3) Patients with anti-TNF agents treatment
4) Patients with food allergy
5) Patients less than 20 years old.
6) Patients with xerosis cutis and impossible to measure body composition
7) Patients judged to be inappropriate for this study from the doctor in charge.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Ito |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
juki@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Yasueda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
Homepage URL
a-yasueda@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School Department of Complementary and Alternative Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Graduate School Department of Gastroenterology
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 10 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014561
