UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033689 |
|---|---|
| Receipt number | R000038409 |
| Scientific Title | Impacts of energy intake and nutritional characteristics on body composition in patients with pulmonary nontuberculous mycobacterial disease |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2019/02/09 19:55:04 |
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Basic information
Public title
Impacts of energy intake and nutritional characteristics on body composition in patients with pulmonary nontuberculous mycobacterial disease
Acronym
Impact of nutritional characteristics in patients with pulmonary nontuberculous mycobacterial disease
Scientific Title
Impacts of energy intake and nutritional characteristics on body composition in patients with pulmonary nontuberculous mycobacterial disease
Scientific Title:Acronym
Impact of nutritional characteristics in patients with pulmonary nontuberculous mycobacterial disease
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacterial disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impacts of energy intake and nutritional characteristics on body composition and respiratory muscle strength in patients with pulmonary nontuberculous mycobacterial disease.
Basic objectives2
Others
Basic objectives -Others
Energy intake and body composition
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy intake
Key secondary outcomes
Energy and nutrient intakes
Nutritional biomarkers
Body composition
Physical functions (grip strength and gait speed)
Pulmonary function
Respiratory muscle strength
Psychological parameters (appetite, depression, anxiety, and body image)
Frailty
Life style (eating habits, exercise habits, physical activity)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Meet the followings:
1) The patients visiting Respiratory Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute.
2) The patients diagnosed as pulmonary nontuberculous mycobacterial disease by 2007 American Thoracic society guidelines.
Key exclusion criteria
Fall under any of the followings:
1) Under 20 years old
2) Patients who were unable to obtain informed consent
3) Patients diagnosed as dementia or psychiatric disorders by their attending physician
4) Patients diagnosed as ineligible patient for other reasons by their attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Takayama |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Nutrition department
Zip code
Address
2-4-20 Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL
06-6131-1221
hinatabokko0401@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Takayama |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Department of Nutrition
Zip code
Address
2-4-20 Ogimachi, Kita-ku, Osaka-shi, Osaka
TEL
06-6131-1221
Homepage URL
hinatabokko0401@yahoo.co.jp
Sponsor or person
Institute
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
田附興風会医学研究所北野病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 08 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the impacts of energy intake and nutritional characteristics on body composition and respiratory muscle strength in patients with pulmonary nontuberculous mycobacterial disease.
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038409
