UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study of anemia improvement effect of the test food for subjects who have anemia symptom
Title of the study (Brief title)	A verification study of anemia improvement effect of the test food
Region	Japan

Condition
Condition	No applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the anemia improvement effect for the subjects who have anemia symptom by 4 weeks consumption of the test food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Consume one test food a day for 4 weeks. Visit the clinic four weeks after starting consumption of the test food, answer the questionnaire.
Interventions/Control_2	Consume one control food a day for 4 weeks. Visit the clinic four weeks after starting consumption of the control food, answer the questionnaire.
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy females and male aged 20 to 40 years old. (2) Subjects who are distinguished as an anemia. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1)Subjects who receive medical treatment of anemia. (2) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Suguru Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	No disclosure
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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 07 Month 08 Day
Anticipated trial start date	2018 Year 09 Month 20 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 08 Month 21 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038597