UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045099 |
|---|---|
| Receipt number | R000051523 |
| Scientific Title | Effectiveness of an oral nutritional supplement (Lipimain400) for malnourished older patients in rural community |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2023/02/09 09:15:34 |
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Basic information
Public title
Prevention of pressure injuries by an oral nutritional supplement
Acronym
Prevention of pressure injuries by an oral nutritional supplement
Scientific Title
Effectiveness of an oral nutritional supplement (Lipimain400) for malnourished older patients in rural community
Scientific Title:Acronym
Effectiveness of an oral nutritional supplement for malnourished older patients in rural community
Region
| Japan |
Condition
Condition
Pressure injury
Classification by specialty
| Geriatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether an oral nutritional supplement and nutritional intervention by a registered dietitian can improve nutritional status and prevent pressure injuries for older outpatients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Nutritional status evaluated by anthropometry and MNA-SF three month later
Key secondary outcomes
A risk score of pressure injury development
The vitality index
Activities of daily living by the Barthel index
Pressure injury's status by DESIGN-R2020
Serum albumin level
Dietary intakes by the 24-hour recall method three month later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Patients take a oral nutritional supplement (120g, 400kcal, Protein 5.2g) every day for three months
Interventions/Control_2
In addition to the same oral nutritional supplement, patients receive nutritional education by a registered dietitian in outpatient or home care setting once a month.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients at risk of malnutrition (11 or less of MNA-SF or <3.5g/dL of serum albumin level) who regularly visit the hospital three month or more.
Key exclusion criteria
Severe conditions of mental illness or other diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kunio |
| Middle name | |
| Last name | Tsukada |
Organization
The Japanese Society of Pressure Ulcers Homecare Association
Division name
President
Zip code
169-0072
Address
Shunkosha Inc. Lamdax Building, 2-4-12 Ohkubo, Shinjuku-ku, Tokyo
TEL
03-5291-6231
care@zaitaku-jokusou.info
Public contact
Name of contact person
| 1st name | Mutsuko |
| Middle name | |
| Last name | Sanai |
Organization
The Kuriyama Red Cross hospital
Division name
Medical care engineering department nourishment section
Zip code
069-1513
Address
3-2 Asahi, Kuriyama-cho, Yubari-gun, Hokkaido
TEL
0123-72-1015
Homepage URL
eiyouka@kuriyama.jrc.or.jp
Sponsor or person
Institute
The Japanese Society of Pressure Ulcers Homecare Association
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Pressure Ulcers Homecare Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Kuriyama Red Cross hospital
Address
3-2 Asahi, Kuriyama-cho, Yubari-gun, Hokkaido
Tel
0123-72-1015
eiyouka@kuriyama.jrc.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
| 2021 | Year | 08 | Month | 18 | 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
23
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
| 2021 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 21 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | 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=R000051523
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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