UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading
Title of the study (Brief title)	Alteration of Airway Inflammatory state after intravenous L-Arginine loading(AILA)
Region	Japan

Condition
Condition	Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons.
Classification by specialty	Clinical immunology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The L-arginine loading test is widely used as a growth hormone provocative test. Intravenously injected L-arginine has been known to stimulate growth hormone secretion, but also serves as a substrate for nitric oxide production which potentially increases airway inflammatory markers, such as fraction exhaled nitric oxide (FeNO). Previous studies indicated that nebulized L-arginine and administrating L-arginine increase FeNO. Since pteridines works as co-enzyme for NO synthase (NOS), low levels of pteridines have been known to induce reactive oxygen species (ROS) instead of producing NO. Based on these facts, we hypothesize L-arginine loading will increase NO production with exhausting NOS co-enzyme, pteridines, and result in generating excessive reactive oxygen species (ROS) to aggravate airway inflammation.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The alteration rate of oxidative stress level before L-arginine loading and 120 minutes after.
Key secondary outcomes	In addition to the above mentioned items, the following items is investigated, including; (1) The alteration rate of oxidative stress level, arginine level, pteridines level before L-arginine loading and 30,60,90,120 minutes after and next day in serum. (2) Correlation between FeNO and oxidative stress level at each point. (3) Correlation between FeNO and pteridines level at each point. (4) Correlation between oxidative stress level and pteridines level at each point.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutes
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	2 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants are scheduled to be examined by intravenous L-arginine loading test with short stature less than -2.0 standard deviation (SD) and/or low growth velocity <-1.5SD over 2 years of follow-up for age and sex, or another reasons their pediatric endocrinologist judge the L-arginine provocative test is necessary. They should be over 2 years old and under 16 years old , and give informed consent on the basis that the study is approved by each local ethics committee.
Key exclusion criteria	Exclusion criteria are following items 1)Patients who are diagnosed with allergy of L-arginine 2) Patients who have used any steroid medications within one month 3) Either the investigator or the co-investigator judged as inappropriate patient for this clinical research
Target sample size	15

Research contact person
Name of lead principal investigator	Haruo Shintaku
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Pediatrics
Address	1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka
TEL	06-6645-3816
Email	m2017993@med.osaka-cu.ac.jp

Public contact
Name of contact person	Saki Kasuga
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Pediatrics
Address	1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka
TEL	06-6645-3816
Homepage URL
Email	m2017993@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 07 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 07 Day
Last modified on	2017 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031226