UMIN-CTR Clinical Trial

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
Email	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
Email	s7003@nms.ac.jp

Sponsor
Institute	Graduate School of Medicine, Nippon Medical School
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	Nippon Medical School
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027935

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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