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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031528
Receipt No. R000036003
Scientific Title Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Date of disclosure of the study information 2018/03/02
Last modified on 2019/03/04

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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 -2nd trial
Acronym Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Scientific Title Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Scientific Title:Acronym Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
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 improves 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 of VAS (Visual Analogue Scale) for overall fatigue from baseline
(Time frame: Baseline, week 0, week 4, and week 8)
Key secondary outcomes 1) Change of VAS for fatigue due to work, work efficiency, and fatigue when one wakes up, from baseline
(Time frame: Baseline, week 0, week 4, and week 8)
2) Change of POMS2 (Profile of Mood States 2nd Edition-Adult)-T scores of Fatigue-Inertia and Vigor-Activity from baseline
(Time frame: Baseline, week 0, week 4, and week 8)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
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 8 weeks.
Interventions/Control_2 Subjects receive 3 placebo tablets/day containing a total of 34.5 mg of sodium ferrous citrate (3.6 mg as Fe) for 8 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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy with physical fatigue on a day-to-day basis (VAS>=40 mm at baseline)
2) POMS2-T score of Fatigue-Inertia >=50, and POMS2-T score of Vigor-Activity<=60 at baseline
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) Judged as ineligible by clinical investigators
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiko Higashikawa
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Probiotic Science for 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 Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Probiotic Science for 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
2018 Year 03 Month 02 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
2018 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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
2018 Year 03 Month 01 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036003

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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