UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008057 |
|---|---|
| Receipt number | 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 21:34:10 |
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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
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
shira@marianna-u.ac.jp
Sponsor or person
Institute
St. Mariannna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009489
