Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060520) titled 'preliminary study aims to evaluate the absorption of calcium formulations' on Jan. 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Universal Calcium Food Co., Ltd.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate of the absorption of calcium formulations and examine protocol optimization of this study protocol
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Washout>Test Food 1>Test Food 2>Test Food 3
Washout& Test Food 1> Washout& Test Food 2> Washout& Test Food 3
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1)Healthy Japanese males and females aged 20 years old or older but under 70 at the time of consent.
2)Employees of Universal Calcium Food Co., Ltd. and students of the Faculty of Biology-Oriented Science and Technology, KINDAI UNIVERSITY.
3)Individuals who have received sufficient explanation about the study and have signed the informed consent form prior to the study initiation.
Key exclusion criteria - 1)Individuals who have been advised by a physicians or other healthcare professionals to restrict the intake of calcium-containing foods or supplements.
2)Individuals with food allergies or those who may be allergic to the test food.
3)Individuals who are pregnant or breastfeeding
4)Individuals who participated in another clinical trial within one month prior to the date of consent, or plan to participate in another clinical trial during the study period.
5)Individuals deemed inappropriate for participation by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 07 Day
Date of IRB - 2026 Year 01 Month 14 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069126
Disclaimer: Curated by HT Syndication.