UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term intake safety evaluation of folic acid supplement aimed to prepare physical condition before pregnancy
Title of the study (Brief title)	Long-term intake safety evaluation of folic acid supplement aimed to prepare physical condition before pregnancy
Region	Japan

Condition
Condition	Premenopausal healthy women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate safety when long-term intake
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the changes before and after the blood data when ingested for 12 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Continue to take supplement for 12 weeks
Interventions/Control_2
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	Not applicable
Gender	Female
Key inclusion criteria	Premenopausal healthy women
Key exclusion criteria	1. Subjects with a history of food allergies 2. Breastfeeding subjects 3. Subjects taking drugs that can bring about effects 4. Subjects taking healthy foods that can bring about an effect
Target sample size	12

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan Clinical Trial Association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Email	info@yakujihou.org

Public contact
Name of contact person	Takeshi Kaneko
Organization	Japan Clinical Trial Association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

Funding Source
Organization	Gennai Seiyaku 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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 04 Month 12 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 04 Month 11 Day
Last modified on	2018 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036719