UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020169
Receipt number R000023296
Scientific Title Effect of ingestion of Vitamin D3 on Upper respiratory tract infection of healthy Japanese adult.
Date of disclosure of the study information 2015/12/13
Last modified on 2016/09/01 15:40:59

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Basic information

Public title

Effect of ingestion of Vitamin D3 on Upper respiratory tract infection of healthy Japanese adult.

Acronym

Effect of Vitamin D3 on Upper respiratory tract infection.

Scientific Title

Effect of ingestion of Vitamin D3 on Upper respiratory tract infection of healthy Japanese adult.

Scientific Title:Acronym

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

1st name
Middle name
Last name Kazutada Egawa

Organization

Nihonbashi Egawa Clinic

Division name

Director

Zip code


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

1st name
Middle name
Last name Yoshiki Shimizu

Organization

FANCL CORPORATION

Division name

Research institute

Zip code


Address

Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, Japan

TEL

045-820-3522

Homepage URL


Email

shimizu_yoshiki@fancl.co.jp


Sponsor or person

Institute

FANCL CORPORATION

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

2015 Year 12 Month 11 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023296


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name