UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010990 |
|---|---|
| Receipt number | R000012864 |
| Scientific Title | Influence of enteral formula containing EPA/DHA on inflammation and iron metabolism in tube-fed elderly patients |
| Date of disclosure of the study information | 2013/06/18 |
| Last modified on | 2013/06/18 10:07:53 |
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Basic information
Public title
Influence of enteral formula containing EPA/DHA on inflammation and iron metabolism in tube-fed elderly patients
Acronym
Influence of enteral formula containing EPA/DHA on inflammation
Scientific Title
Influence of enteral formula containing EPA/DHA on inflammation and iron metabolism in tube-fed elderly patients
Scientific Title:Acronym
Influence of enteral formula containing EPA/DHA on inflammation
Region
| Japan |
Condition
Condition
chronic inflammation, abnormal iron metabolism
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of enteral formula containing EPA/DHA on chronic inflammation and abnormal iron metabolism in tube-fed elderly patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hs-CRP, IL-6, TNF-alpha, hepcidin, serum iron, ferritin, total iron-binding capacity, transferrin, hemoglobin
Key secondary outcomes
EPA, DHA, EPA/AA ratio, triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol, adiponectin, leptin, MCP-1, resistin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of enteral formula containing EPA/DHA for 8 weeks, while maintaining the total energy intake.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bedridden elderly patients receiving total enteral nutrition, who are stable.
Key exclusion criteria
1)Patients receiving enteral formula containing EPA/DHA.
2)Patients with hepatic, renal, cardiovascular, respiratory and intestinal dysfunction, persistent infection and malignancy.
3)Patients with allergy to milk, soybean and fish oil, which are contained in the enteral formula.
4)Patients judged as inappropriate for the study by the physician in charge.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Akatsu |
Organization
Fukushimura Hospital
Division name
Choju Medical Institute
Zip code
Address
19-14, Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Akatsu |
Organization
Fukushimura Hospital
Division name
Choju Medical Institute
Zip code
Address
19-14, Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL
0532-46-7511
Homepage URL
Sponsor or person
Institute
Fukushimura Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinico Co., Ltd.
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
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
| 2010 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 18 | Day |
Last modified on
| 2013 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012864
