UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037811 |
|---|---|
| Receipt number | R000043045 |
| Scientific Title | Effects of nutritional intervention for high risk patients of pressure ulcer |
| Date of disclosure of the study information | 2019/08/30 |
| Last modified on | 2019/08/27 10:22:02 |
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Basic information
Public title
Effects of nutritional intervention for high risk patients of pressure ulcer
Acronym
Effects of nutritional intervention for high risk patients of pressure ulcer
Scientific Title
Effects of nutritional intervention for high risk patients of pressure ulcer
Scientific Title:Acronym
Effects of nutritional intervention for high risk patients of pressure ulcer
Region
| Japan |
Condition
Condition
high risk patients of pressure ulcer
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the influence on abdominal circumference and nutritional status by comparing the cases of 1200 Kcal / day and 900 Kcal / day
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
abdominal circumference
Key secondary outcomes
risk assessment for pressure ulcer, body weight, bony prominences, skinfold thickness of iliac spine, TLC, T-chol, CRP, CRE, BUN, Alb, TP, Hb, fecal properties, frequency of defecation treatment, incidence of pressure ulcer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Polymeric formula: 900 Kcal/day
Interventions/Control_2
Polymeric formula: 1200 Kcal/day
Interventions/Control_3
Oligomeric formula: 900 Kcal/day
Interventions/Control_4
Oligomeric formula: 1200 Kcal/day
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients on OH scale: 5.5 or more
2)Patients on tube feeding, not oral intake
3)Patients on tube feeding, not oral intake
4)Patients on NG tube or PEG
5)Patients on 800-900 Kcal/day
6)Patients without pressure ulcer
7)Patients informed consent
8)Patients over 60 years old and under 99 years old
Key exclusion criteria
1)Patients with AST > 100 U/L or ALT > 100 U/L
2)Patients with HbA1c > 8.0 %
3)Patients with Cre > 2.0 mg/dL or BUN > 44 mg/dL
4)Patients with ASO
5)Patient who have an allergy to soy, gelatin, milk component
6)Patients treated with chemotherapy or radiotherapy
7)Patients with other conditions not suitable for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Ohura |
Organization
Pressure Ulcer & Wound Healing Research Center
Division name
recearch center
Zip code
060-0063
Address
1-1, Minami 3-jo Nishi 2-chome Chuo-ku, Sapporo 060-0063 Japan
TEL
011-232-2208
t-ohura@mb.snowman.ne.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Ohura |
Organization
Pressure Ulcer & Wound Healing Research Center
Division name
recearch center
Zip code
060-0063
Address
1-1, Minami 3-jo Nishi 2-chome Chuo-ku, Sapporo 060-0063 Japan
TEL
011-232-2208
Homepage URL
t-ohura@mb.snowman.ne.jp
Sponsor or person
Institute
Pressure Ulcer & Wound Healing Research Center
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Dermatology Clinic IRB
Address
1-1, Minami 3-jo Nishi 2-chome Chuo-ku, Sapporo 060-0063 Japan
Tel
011-221-8807
akira-ookawara@hokkaido.med.or.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
| 2019 | Year | 08 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043045
