UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031528
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

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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 or person

Institute

Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.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