UMIN-CTR Clinical Trial

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
Email	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
Email	t-ohura@mb.snowman.ne.jp

Sponsor
Institute	Pressure Ulcer & Wound Healing Research Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043045