UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022825 |
|---|---|
| Receipt number | R000026309 |
| Scientific Title | Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2017/06/22 13:04:42 |
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Basic information
Public title
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Acronym
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Scientific Title
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Scientific Title:Acronym
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of oral coadministration of 5-aminolevulinic acid phosphate (250 mg/day) with sodium ferrous citrate (143.4 mg/day).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse event including laboratory abnormality and the change of CTCAE grade
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive 250 mg/day of 5-aminolevulinic acid phosphate and 143.4 mg/day of sodium ferrous citrate (15 mg as Fe) for 28 days.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy
Key exclusion criteria
1) Taking medicines for chronic disease
2) Taking functional food that may affect the trial
3) Participation in any clinical trial within 90 days of the commencement of the trial
4) In pregnancy or nursing a child
5) History of severe disease and/or major surgery
6) History of hypersensitivity caused by 5-aminolevulinic acid or porphyrin
7) Subject or family history of diagnosis of porphyria
8) Severe anemia (Hemoglobin < 10 g/dL)
9) Judged as ineligible by clinical investigators
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
Homepage URL
fumiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd., Japan
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 22 | 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
| 2016 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | 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
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026309
