UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003329 |
|---|---|
| Receipt number | R000004042 |
| Scientific Title | Influence that carnitine replenishment with total parenteral nutrition gives to serum albumin value. |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2010/03/13 11:25:17 |
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Basic information
Public title
Influence that carnitine replenishment with total parenteral nutrition gives to serum albumin value.
Acronym
Study of TPN and carnitine.
Scientific Title
Influence that carnitine replenishment with total parenteral nutrition gives to serum albumin value.
Scientific Title:Acronym
Study of TPN and carnitine.
Region
| Japan |
Condition
Condition
eating disorder,cerebral palsy
Classification by specialty
| Gastroenterology | Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Decrease of serum albumin value is often admitted in handicapped child who is doing the passing tube nourishment. Because the carnitine is not contained in a lot of passing tube nourishment medicines, the change in the serum albumin by the carnitine replenishment is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood calculation and biochemistry inspection (TP, Alb, AST, ALT, T-Bil, BUN, Cre, Tcho.TG, ferritin, transferrin, and thyroid gland function TSH, fT3, fT4, Fe, Cu, Mg, and Zn),free carnitine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The adjustment powdered milk including the carnitine is administered as carnitine replenishment.
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
| 0 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Complete parenteral nutrition continues for one month or more.
Key exclusion criteria
1)The allergy to the adjustment powdered milk is possessed.
2)Object person contract a clear acute disease.
3)Doctor is suitable positive.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ushio Ohtaki |
Organization
Shimada Center for Rehabilitation and Neurodevelopmental Intervention, Tama, Tokyo
Division name
Pediatrics
Zip code
Address
Nakazawa 1-31-1, Tama city ,Tokyo.
TEL
042-374-2071
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ushio Ohtaki |
Organization
Shimada Center for Rehabilitation and Neurodevelopmental Intervention, Tama, Tokyo
Division name
pediatrics
Zip code
Address
TEL
042-374-2071
Homepage URL
Sponsor or person
Institute
Shimada Center for Rehabilitation and Neurodevelopmental Intervention, Tama, Tokyo
Institute
Department
Personal name
Funding Source
Organization
Shimada Center for Rehabilitation and Neurodevelopmental Intervention, Tama, Tokyo
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
島田療育センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | 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
| 2010 | Year | 03 | Month | 13 | Day |
Last modified on
| 2010 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004042
