UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056969 |
|---|---|
| Receipt number | R000065097 |
| Scientific Title | Nutritional therapy in the prevention of weight loss in patients with interstitial lung disease: a prospective observational study |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/07 13:57:48 |
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Basic information
Public title
Nutrition for interstitial lung disease patients to avoid weight loss
Acronym
Nutrition Research for Interstitial Lung Disease
Scientific Title
Nutritional therapy in the prevention of weight loss in patients with interstitial lung disease: a prospective observational study
Scientific Title:Acronym
ILDNUTRI
Region
| Japan |
Condition
Condition
Interstitial Lung Diasease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Idiopathic pulmonary fibrosis IPF an interstitial lung disease, is said to be a lung disease of unknown cause with a poor prognosis that results in severe fibrosis and irreversible honeycomb lung formation. The mainstay of drug therapy is antifibrotic agents, but the cumulative incidence of discontinuation of drug therapy is reported to be higher in the presence of malnutrition than in the absence of malnutrition. Other studies have shown that weight loss of 5 percentage or more during the first year after initiation of nintedanib is associated with a worse prognosis compared to patients with no weight loss. Thus it can be inferred that there is a relationship between interstitial lung disease, drug therapy, and nutritional status, which may influence prognosis.One of the non-pharmacologic therapies is respiratory rehabilitation PR and the IPF Treatment Guidelines 2023 suggest PR for patients with IPF in the chronic phase. The Self-Management Support Manual for Patients with Respiratory Diseases does provide information on nutritional therapy but its focus is primarily on chronic obstructive pulmonary disease COPD. The guidelines for enteral nutrition also target COPD. These guidelines emphasize the importance of starting nutritional therapy at an early stage, and specify that patients with less than 90 persentage body weight are eligible for such therapy. Thus, in order to continue treatment of ILD it is important to assess nutritional status from the beginning of treatment and to implement appropriate nutritional therapy. Therefore, the development of nutritional therapy for IP is desirable, but as far as we know, there are no other studies from this perspective. Therefore the purpose of this study was to examine the effect of nutritional therapy on weight loss prevention in patients with ILD and to accumulate knowledge that could contribute to the prevention of severe disease and the continuation of treatment in patients with ILD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Percent weight loss more than 5 percent at 52 weeks
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with interstitial lung disease of any cause.
2) Patients requiring outpatient and inpatient care at the Respiratory Medicine Department of our center.
3) Patients with a % standard body weight ratio (% IBW) of less than 90%.
4) Patients who have given a full explanation of the study and obtained written consent from the patient.
Key exclusion criteria
1) Those who are not eligible for nutritional guidance.
2) Those whose % standard body weight ratio (% IBW) is greater than 90%.
3) Those who cannot give consent for this study.
4) Those who do not meet the diagnosis of eligibility criteria.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishikawa |
Organization
Japanese Red Cross Medical Center
Division name
Nutrition Division, Department of Medical Technology
Zip code
150-8935
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
nutr.23@gmail.com
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Inomata |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
1508935
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
Homepage URL
inomataminoru@nms.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Medical Center Clinical Research Ethics Committee
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
Tel
0334001311
nutr.23@gmail.com
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
| 2025 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association between continued nutritional therapy and improvement in quality of daily life
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065097
