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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000024260 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Idiopathic interstitial pneumonias | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |