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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008038
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute SBI Pharmaceuticals Co., Ltd
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009466

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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