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
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
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
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
