UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Title of the study (Brief title)	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	Fumiko Higashikawa
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Probiotic Science for Preventive Medicine
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	Fumiko Higashikawa
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Probiotic Science for Preventive Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036003