UMIN-CTR Clinical Trial

Public title

Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading

Acronym

Alteration of Airway Inflammatory state after intravenous L-Arginine loading(AILA)

Scientific Title

Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading

Scientific Title:Acronym

Alteration of Airway Inflammatory state after intravenous L-Arginine loading(AILA)

Region

Japan

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

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Haruo Shintaku

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

Address

1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka

TEL

06-6645-3816

Email

m2017993@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Saki Kasuga

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

Address

1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka

TEL

06-6645-3816

Homepage URL

Email

m2017993@med.osaka-cu.ac.jp

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2017

Year

01

Month

11

Day

Date of IRB

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

Other related information

Registered date

2017

Year

05

Month

07

Day

Last modified on

2017

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031226