Unique ID issued by UMIN | UMIN000031528 |
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Receipt number | 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 09:36:11 |
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects -2nd trial
Japan |
Healthy volunteers
Adult |
Others
NO
To determine whether 5-aminolevulinic acid phosphate with sodium ferrous citrate improves physical fatigue in healthy subjects.
Efficacy
Confirmatory
Pragmatic
Not applicable
Change of VAS (Visual Analogue Scale) for overall fatigue from baseline
(Time frame: Baseline, week 0, week 4, and week 8)
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
YES
Central registration
2
Prevention
Food |
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.
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.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
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
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
70
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Graduate School of Biomedical and Health Sciences, Hiroshima University
Department of Probiotic Science for Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Graduate School of Biomedical and Health Sciences, Hiroshima University
Department of Probiotic Science for Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
Hiroshima University
SBI ALApromo Co., Ltd.
Profit organization
NO
広島大学病院(広島県)
2018 | Year | 03 | Month | 02 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 14 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036003
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