UMIN-CTR Clinical Trial

Basic information
Public title	Verification of changes in urinary vitamin D metabolites and beta-carotene due to vitamin D and beta-carotene supplementation in healthy subjects - Open-label study-
Acronym	Verification of changes in urinary vitamin D metabolites and beta-carotene due to vitamin D and beta-carotene supplementation in healthy subjects - Open-label study-
Scientific Title	Verification of changes in urinary vitamin D metabolites and beta-carotene due to vitamin D and beta-carotene supplementation in healthy subjects - Open-label study-
Scientific Title:Acronym	Verification of changes in urinary vitamin D metabolites and beta-carotene due to vitamin D and beta-carotene supplementation in healthy subjects - Open-label study-
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate changes in urinary markers with continuous intake of vitamin D and beta-carotene.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentrations of vitamin D metabolites in urine and beta-carotene in urine (0w,4w,8w,12w)
Key secondary outcomes	Vitamin D and beta-carotene sufficiency scores estimated from urinary markers(0w,4w,8w,12w)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	One tablet of each of the test foods (30.0 microgram of vitamin D and 1.9 mg of beta-carotene) will be taken once a day 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: 20-64 2) BMI: 18.5 kg/m2-25.0 kg/m2 3) Subjects who giving informed consent
Key exclusion criteria	1) Subjects who visit a hospital for treatment or take medicine for treatment. 2) Subjects who are under nutritional guidance or on a restricted diet. 3) Females who are pregnant, breast-feeding. 4) Subjects who with gelatin allergies. 5) Subjects who have taken vitamin D-containing or beta-carotene containing supplements at least 3 days per week for the past 3 months. 6) Subjects who have taken 3 or more servings of vegetable juice per week for the past 3 months. 7) Subjects who ate at least one piece of fish every day for the past 3 months. 8) Subjects who habitually engage in activities that involve tanning or sunbathing (leisure, commuting, etc.). 9) Females who are menstruating at the time of urine collection.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute
Zip code	244-0806
Address	12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3532
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Goto
Organization	Kenkoin Medical Corporation Foundation
Division name	Kenkoin Clinic
Zip code	104-0061
Address	6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL	03-3573-1153
Homepage URL
Email	akiko-goto@kenkoin.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address	6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel	03-3573-1153
Email	isamu-yanase@kenkoin.jp

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	医療法人財団健康院　健康院クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 15 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	29
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	2021 Year 08 Month 26 Day
Date of IRB	2021 Year 08 Month 31 Day
Anticipated trial start date	2021 Year 10 Month 19 Day
Last follow-up date	2022 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051680