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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008057
Receipt No. R000009489
Scientific Title Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease
Date of disclosure of the study information 2012/06/06
Last modified on 2017/05/10

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Basic information
Public title Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease
Acronym Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease
Scientific Title Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease
Scientific Title:Acronym Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease
Region
Japan

Condition
Condition Parkinson's Disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the administration effects of the enteral formula enriched with omega-3 fatty acid to nutritional status, ghrelin , leptin and Parkinson's disease clinical evaluation scale in patients with Parkinson's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Body weight reduction rate ,amount of PD clinical evaluation scale score change (Total score by each part of UPDRS )
Key secondary outcomes Change rate of albumin, prealbumin, acyl-ghrelin, desacyle-ghrelin, leptin

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
Interventions/Control_1 Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.
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
35 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Male and female patients aged 35 years old and above and less than 80 years old at the time of informed consent.
2. Patients who have lost a weight 5% and above unintentionally within past 6 to 12 months.
3. Patients who are capable of consent and have given voluntary written informed consent.
4. Patients who have benefit of L-DOPA drug at the start of administration.
5. Patients who have administrated L-DOPA and DCA combination drugs more than 6 months consecutively.
6. Patients with stable dosage and administration of antiparkingon's disease drugs before 2 weeks of observation period.
7. Patients who are able to follow the study schedule.
Key exclusion criteria 1. Patients with parkinsonian syndrome
2. Patients have participated in the other studies or clinical trials of enteral nutrition formula.
3. Patients who have received surgical treatment such as stereotactic neurosurgery within 6 months.
4. Patients with psychological symptom such as severe confusion, hallucination, delusion and abnormal behavior.
5. Patients with cognitive dysfunction (MMSE score is no more than 21)
6. Patients with a history of drug allergy (Including any ingredient of study drug)
7. Patients who have administrated other study drugs and drug of post-marketing clinical trial within 3 months before observation period and have not completed other studies at the time of informed consent
8. Patients judged to be inappropriate for the study by the investigator.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Shiraishi
Organization St. Mariannna University School of Medicine
Division name Neurology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL 044-976-8516
Email shira@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Shiraishi
Organization St. Mariannna University School of Medicine
Division name Neurology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL 044-976-8516
Homepage URL
Email shira@marianna-u.ac.jp

Sponsor
Institute St. Mariannna University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 06 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 Completed
Date of protocol fixation
2012 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2012 Year 05 Month 30 Day
Last modified on
2017 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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