UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024260 |
|---|---|
| Receipt number | R000027935 |
| Scientific Title | Evaluation of the effects of omega-3 fatty acids for biomarkers of idiopathic interstitial pneumonias (IIPs) with hypertriglyceridemia |
| Date of disclosure of the study information | 2016/10/05 |
| Last modified on | 2020/04/07 16:40:12 |
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Basic information
Public title
Evaluation of the effects of omega-3 fatty acids for biomarkers of idiopathic interstitial pneumonias (IIPs) with hypertriglyceridemia
Acronym
Effects of omega-3 fatty acids for biomarkers of IIPs
Scientific Title
Evaluation of the effects of omega-3 fatty acids for biomarkers of idiopathic interstitial pneumonias (IIPs) with hypertriglyceridemia
Scientific Title:Acronym
Effects of omega-3 fatty acids for biomarkers of IIPs
Region
| Japan |
Condition
Condition
Idiopathic interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate of the effects of omega-3 fatty acids for the biomarkers of IIPs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the biomarkers of IIPs
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
Administration of omega-3 fatty acids
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 with written informed consent.
(2)Patients diagnosed as IIPs (Idiopathic Pulmonary Fibrosis or fibrotic Nonspecific Interstitial Pneumonia)
(3)Patients with hypertriglyceridemia defined as a triglyceride level exceeded 150 mg/dL.
(4)Patients whose serum KL-6 levels exceeded 500 U/mL or serum SP-D levels exceeded 110 ng/mL
Key exclusion criteria
(1)A pregnant woman or the woman who may be pregnant.
(2)Patients who have received immunosuppressants (e.g. Ciclosporin or Cyclophosphamide), pirfenidone, or N-acetylcysteine within 6 months prior to participation.
(3)Patients who began oral corticosteroids therapy within 6 months prior to participation.
Patients who have received high-dose corticosteroids (>10 mg prednisolone daily)
(4)Patients taking DHA or EPA within 3 months prior to participation
(5)Patients with unstable IIPs.
(6)Patients with severe anemia, liver disease, renal disease, heart disease or bleeding.
(7)In addition, the patients who are not eligible for participation judged by a doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Atsumi |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Pulmonary Medicine and Oncology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
s7003@nms.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Atsumi |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Pulmonary Medicine and Oncology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
s7003@nms.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Nippon Medical School
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
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027935
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
