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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name