UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023132
Receipt number R000026383
Scientific Title Multicenter study of efficacy of modified atkins diet in patients with glycogen storage disease type 3a and 3d
Date of disclosure of the study information 2016/07/12
Last modified on 2017/07/26 21:38:12

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Basic information

Public title

Multicenter study of efficacy of modified atkins diet in patients with glycogen storage disease type 3a and 3d

Acronym

Multicenter study of efficacy of modified atkins diet in patients with glycogen storage disease type 3

Scientific Title

Multicenter study of efficacy of modified atkins diet in patients with glycogen storage disease type 3a and 3d

Scientific Title:Acronym

Multicenter study of efficacy of modified atkins diet in patients with glycogen storage disease type 3

Region

Japan


Condition

Condition

glycogen storage disease type 3a and 3d

Classification by specialty

Hepato-biliary-pancreatic medicine Cardiology Neurology
Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of modified atkins diet on cardiomyopathy and myopathy in patients with glycogen storage disease type 3a and 3b

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

muscle CT, motor function, cardiac function, and cardiomegaly

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

modified Atkins diet

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

1 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

glycogen storage disease type 3
high serum CK

Key exclusion criteria

1.Patients with recurrent severe hypoglycemia
2.Pregnant breast-feeding (within a year after delivery) patients
3.Patients with disorders of fatty acid metabolism, disorders of ketone body metabolism, pyruvate carboxylase deficiency, and porphyria
4.Patients with carnitine deficiency

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tokiko Fukuda

Organization

Hamamatsu University School of Medicine

Division name

Pediatrics

Zip code


Address

Handayama 1-20-1, Higashi ku, HamamatsuCity

TEL

053-435-2312

Email

toki-fkd@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tokiko Fukuda

Organization

Hamamatsu University School of Medicine

Division name

Pediatrics

Zip code


Address

Handayama 1-20-1, Higashi ku, HamamatsuCity

TEL

053-435-2312

Homepage URL


Email

toki-fkd@hama-med.ac.jp


Sponsor or person

Institute

Pediatrics, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tokoha University
Saitama Medical University

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

浜松医科大学付属病院（静岡県）、埼玉医科大学病院（埼玉県）、随時追加


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 12 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

Open public recruiting

Date of protocol fixation

2015 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 10 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

2016 Year 07 Month 12 Day

Last modified on

2017 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026383


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name