UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of Vitamin D3 on Upper respiratory tract infection of healthy Japanese adult.
Title of the study (Brief title)	Effect of Vitamin D3 on Upper respiratory tract infection.
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effect of ingestion of the vitamin D for consecutive weeks on the upper respiratory tract infection of the healthy Japanese male and female.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence proportion of upper respiratory tract infection during the test period
Key secondary outcomes	Longest duration, most severe physical and mental severity of upper respiratory tract infection during the study period Incidence proportion longest duration, most severe physical and mental severity of upper respiratory tract infection of every 4 weeks of study period

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of 10 micro grams of Vitamin D3 per day for 112 days
Interventions/Control_2	Ingestion of placebo without vitamin D3 for 112 days
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	45 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1.45 to 74 years of age of healthy Japanese subjects 2.BMI between 18.5 to 24.9 kg/m2 3.Defined serum 25-OHD level: less-than-or-equal-to 30 ng/mL (= 75 nmol/L) 4. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements
Key exclusion criteria	1.Current smoker 2.The subject with a serious illness 3.The subject with an illness that influencing results 4.Subjects who are planning to extensively expose one's body to the sun 5.Fasting glucose >110 mg /dl 6.Use of HRT within the previous 6 months 7.Use of dietary supplements while on study, except multi-vitamins, however must stop before enter the study and refrain until the end of the study 8.Use of Vitamin D supplements 9.Use of high dose Calcium supplements >600 mg 10.Hypertension: higher than 145 / 95 mmHG measured in resting position 11.Treatment for hypertension 12.Subjects with a history of a psychological illness or condition which is likely to interfere with the subject's ability to understand the requirements of the study 13.Systematic practice of high intensity exercise (high intensity sports more than 3 times per week) 14.Any condition that might interfere with absorption of the investigational product 15.Dieases that carry a risk for hypercalcemia: Sarcoidosis, Tuberculosis, Lymphoma, primary hyperparathyroidism 16.Kidney stones 17.Creatinine clearance of less than 30 ml/min 18.Known hypersensitivity or allergy to dairy or milk products 19.Co-medications: Anticoagulants,use of steroids in any form, parathyroid hormone, corticosteroids, thiazide diuretic, Anticonvulsants, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali). 20.Use of any drug which might interfere with bone metabolism (biphosphonate, hormone replacement therapy, estrogen receptor modulators, calcitonin) within the precious 12 months 21.None-fat diets, or other extreme dietary habits 22.Subjects on a weight reduction program or a medically supervised diet 23.Signs of acute or severe illness: unintentional weight-loss, night sweats, treatment for cancer 24.Alcohol abuse:>=140g /week 25.Persons judged to be unsuitable as trial subjects by the Principal Investigator or Assistant Investigators
Target sample size	250

Research contact person
Name of lead principal investigator	Kazutada Egawa
Organization	Nihonbashi Egawa Clinic
Division name	Director
Address	1-1-3 Yaesu, Chuo-ku, Tokyo, Japan
TEL	03-5204-0311
Email	egawa_clinic@yahoo.co.jp

Public contact
Name of contact person	Yoshiki Shimizu
Organization	FANCL CORPORATION
Division name	Research institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3522
Homepage URL
Email	shimizu_yoshiki@fancl.co.jp

Sponsor
Institute	FANCL CORPORATION
Institute
Department

Funding Source
Organization	FANCL CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2015 Year 12 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 11 Day
Anticipated trial start date	2015 Year 12 Month 14 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 08 Month 01 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 11 Day
Last modified on	2016 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023296