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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024974
Receipt No. R000028740
Scientific Title Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Date of disclosure of the study information 2016/11/25
Last modified on 2019/04/18

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Basic information
Public title Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Acronym Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Scientific Title Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Scientific Title:Acronym Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether 5-aminolevulinic acid phosphate with sodium ferrous citrate improve physical fatigue in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change from baseline of VAS (Visual Analogue Scale) for physical fatigue (Time frame: Baseline and every day during each administration period)
Key secondary outcomes Change from baseline of salivary IgA and cortisol (Time frame: Baseline and day 5, 6, 12, and 13 during each administration period)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects receive 3 tablets/day containing a total of 30 mg of 5-aminolevulinic acid phosphate and 34.5 mg of sodium ferrous citrate (3.6 mg as Fe) for 2 weeks.
Interventions/Control_2 Subjects receive 3 placebo tablets/day for 2 weeks.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Healthy with physical fatigue on a day-to-day basis
Key exclusion criteria 1) Taking medicines for chronic disease

2) Taking medicines or 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) Judged as ineligible by clinical investigators
Target sample size 20

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
Email 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
Email fumiko@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization SBI ALApromo 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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 25 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 11 Month 16 Day
Date of IRB
2016 Year 11 Month 16 Day
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028740

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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