Unique ID issued by UMIN | UMIN000024974 |
---|---|
Receipt number | 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 09:43:37 |
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Effect of 5-aminolevulinic acid phosphate with sodium ferrous citrate on feeling of physical fatigue in healthy subjects
Japan |
Healthy volunteers
Adult |
Others
NO
To determine whether 5-aminolevulinic acid phosphate with sodium ferrous citrate improve physical fatigue in healthy subjects.
Efficacy
Confirmatory
Pragmatic
Not applicable
Change from baseline of VAS (Visual Analogue Scale) for physical fatigue (Time frame: Baseline and every day during each administration period)
Change from baseline of salivary IgA and cortisol (Time frame: Baseline and day 5, 6, 12, and 13 during each administration period)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
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 2 weeks.
Subjects receive 3 placebo tablets/day for 2 weeks.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
Healthy with physical fatigue on a day-to-day basis
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
20
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and 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 |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and 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)
2016 | Year | 11 | Month | 25 | Day |
Unpublished
Completed
2016 | Year | 11 | Month | 16 | Day |
2016 | Year | 11 | Month | 16 | Day |
2017 | Year | 01 | Month | 04 | Day |
2019 | Year | 02 | Month | 28 | Day |
2016 | Year | 11 | Month | 24 | Day |
2019 | Year | 04 | Month | 18 | Day |
Value
https://center6.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 |