UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016092
Receipt number R000018689
Scientific Title Analysis of the effects of animal fat free diet and aspirin for prostaglandins in patients with myotonic dystrophy
Date of disclosure of the study information 2014/12/31
Last modified on 2018/01/02 10:27:10

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Basic information

Public title

Analysis of the effects of animal fat free diet and aspirin for prostaglandins in patients with myotonic dystrophy

Acronym

Animal fat free diet and aspirin in patients with myotonic dystrophy

Scientific Title

Analysis of the effects of animal fat free diet and aspirin for prostaglandins in patients with myotonic dystrophy

Scientific Title:Acronym

Animal fat free diet and aspirin in patients with myotonic dystrophy

Region

Japan


Condition

Condition

myotonic dystrophy

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Assess the effects of animal fat free diet and aspirin for prostaglandins and their metabolites in patients with myotonic dystrophy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Prostaglandins (PGD2, PGE2, etc.) and their metabolites

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

1st stage (1w): animal fat free diet
2nd stage (1w): animal fat free diet and aspirin (330mg/day)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Genetically confirmed myotonic dystrophy patients who can take ordinary texture diet.

Key exclusion criteria

Patients with severe heart failure, hepatic failure, renal failure, hematological disorders, bleeding tendency or active illnesses (infection, allergic disorders).
Patients taking anticoagulant or antiplatelet agents.
Patients with active gastrointestinal ulcers.
Patients in pregnancy
Patients having history of any allergic responses for aspirin.
Patients taking anti-inflammaotry or antiallergic agents.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuyoshi Matsumura

Organization

National Hospital Organization Toneyama National Hospital

Division name

Neurology

Zip code


Address

Toneyama 5-1-1, Toyonaka, Osaka

TEL

06-6853-2001

Email

tmatsumura-toneyama@umin.org


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiko Tsuchie

Organization

National Hospital Organization Toneyama National Hospital

Division name

Clinical research center

Zip code


Address

Toneyama 5-1-1, Toyonaka, Osaka

TEL

06-6853-2001

Homepage URL


Email

chiken@toneyama.go.jp


Sponsor or person

Institute

National Hospital Organization Toneyama National Hospital

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Toneyama National Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Graduate school of engineering Osaka 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

独立行政法人国立病院機構刀根山病院(大阪府)
大阪大学大学院工学研究科(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

T.Chol, LDL and TG were decerased by animal fat free diet.
TBX2 was greatly reduced by aspirin, which confirmed COX inhibitory effect.
PGD2 was below detection limint in five patients. In the remaining patients, PGD2 was mildly reduced by animal fat free diet, and greatly reduced by aspirin. Two patients improved in myotonia, and one patient felt easiness in movements. These facts suggested the effect of PGD2 inhibition.
On the other hand, there were no changes in PGE2.This was the first experience to measure human PGs by supercritical fluid chromatography. We need some technical improvements.

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

Main results already published

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2017 Year 07 Month 31 Day

Date analysis concluded

2017 Year 10 Month 10 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 31 Day

Last modified on

2018 Year 01 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018689


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name