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
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
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
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
