UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008038 |
|---|---|
| Receipt number | R000009466 |
| Scientific Title | Satefy evaluation of a health food containing 5-aminolevulinic acid and ion for diabetic patients |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2013/06/28 17:45:10 |
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Basic information
Public title
Satefy evaluation of a health food containing 5-aminolevulinic acid and ion for diabetic patients
Acronym
Safety evaluation of 5-ALA for diabetic patients
Scientific Title
Satefy evaluation of a health food containing 5-aminolevulinic acid and ion for diabetic patients
Scientific Title:Acronym
Safety evaluation of 5-ALA for diabetic patients
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety (espacially occurrence of hypoglycemic attack) of a health food containing 5-aminolevulinic acid and ion for diabetic patients receiving oral anti-diabetic drug(s) whose ages are from 30 to 75.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety and occurrence of hypoglycemic attack
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
First group: test food (5-ALA Amg)
Interventions/Control_2
Second group: test food (5-ALA Bmg)
Interventions/Control_3
Third group: placebo food (5-ALA 0mg)
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Man or woman whose age is from 30 to 75 when the informed consent is obtained.
2. Diabetic patient taking more than one of the following drugs ;sulfonylurea,
thiazolidine-derivative, DPP-4 inhibitor, or metformin.
3. No history of hypoglycemic attack for 3 months before entry and supposed no change of anti-diabetic drugs during the clinical study
Key exclusion criteria
1. A patient injecting insulin.
2. Severe disease condition (renal disease, liver disease, heart disease etc).
3. A patient who is taking the following drug; anti-convulsant, antiarrhythmic agent, or coronary vasodilator.
4. A woman who is pregnant or may be pregnat, or who is lactating.
5. A patient who is enrolled in another clinical trial, or who had been enrolled in another clinical trial within the past 3 months.
6. A patient allergic for medical drug and food.
7. Uncontrolled alcoholism or severe mental disorder.
8. A patient who is judged by the doctor as not eligible to this study.
etc.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohide Yamashita |
Organization
Research Hospital, Institute of Medical Science, University of Tokyo
Division name
Internal Medicine
Zip code
Address
4-6-1 Shirokanedai, Mitato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Division of Clinical Study
Zip code
Address
TEL
03-6801-8480
Homepage URL
Sponsor or person
Institute
SBI Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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 | 05 | Month | 28 | 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
5-ALA(15mg/day, 50mg/day)could be safely ingested in diabetic patients treated with OHA.
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 | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 28 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2013 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009466
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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