UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005806 |
|---|---|
| Receipt number | R000006699 |
| Scientific Title | A study on blood concentrations of vitamins and trace elements and hair concentration of trace elemens in the patients receiving long-term home parenteral nutrition |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2018/12/25 09:33:14 |
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Basic information
Public title
A study on blood concentrations of vitamins and trace elements and hair concentration of trace elemens in the patients receiving long-term home parenteral nutrition
Acronym
A study on the concentrations of vitamins and trace elements in HPN patients
Scientific Title
A study on blood concentrations of vitamins and trace elements and hair concentration of trace elemens in the patients receiving long-term home parenteral nutrition
Scientific Title:Acronym
A study on the concentrations of vitamins and trace elements in HPN patients
Region
| Japan |
Condition
Condition
Benign gastrointestinal diseases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the required amounts of vitamins and trace elements, as well as the relations between nutritional status and trace element deficiencies in the patients receiving long-term home parenteral nutrition by measuring the blood trace element concentration, hair trace element concentration, and changes in the blood vitamin concentration and parameters related to nutritional status.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood concentrations of Fe, Zn, Cu, Mn, and Se.
Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid.
Hair concentration of trace elements
Key secondary outcomes
Blood concentrations of Fe, Zn, Cu, Mn, and Se.
Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid.
Hair concentration of trace elements
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
Patients with benign gastrointestinal diseases who meet the following criteria.
1. 20 years or older
2. Male or female
3. Able to provide written informed consent based on a complete understanding of the study requirements
Key exclusion criteria
Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Washizawa |
Organization
Toho University Medical Center Omori Hospital
Division name
Nutrition Therapy Center
Zip code
Address
Omori-Nishi6-11-1,Ota-ku,Tokyo
TEL
03-3762-4151
washi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Washizawa |
Organization
Toho University Medical Center Omori Hospital
Division name
Nutrition Therapy Center
Zip code
Address
Omori-Nishi6-11-1,Ota-ku,Tokyo
TEL
03-3762-4151
Homepage URL
washi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Omori Hospital
Institute
Department
Personal name
Funding Source
Organization
Toho niversity
Organization
Division
Category of Funding Organization
Self funding
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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 21 | 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
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Nutritional assessment with anthropometry. Blood concentrations of Fe, Zn, Cu, Mn, and Se.Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid.Hair concentration of trace elements.Serum concentration of total protein,albumin,choline esterase,
total cholesterol,fatty acid fraction in blood C-reactive protein.
Management information
Registered date
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006699
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
