UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019304 |
|---|---|
| Receipt number | R000022325 |
| Scientific Title | Effect of oral ingestion of Vitamin D3 on lower limb function, bone markers, blood pressure, indicators of the innate immunity system and QOL in post-menopausal Japanese women. |
| Date of disclosure of the study information | 2015/10/12 |
| Last modified on | 2016/07/29 14:14:47 |
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Basic information
Public title
Effect of oral ingestion of Vitamin D3 on lower limb function, bone markers, blood pressure, indicators of the innate immunity system and QOL in post-menopausal Japanese women.
Acronym
Effect of oral ingestion of Vitamin D3 on lower limb function, bone markers, blood pressure, indicators of the innate immunity system and QOL in post-menopausal Japanese women.
Scientific Title
Effect of oral ingestion of Vitamin D3 on lower limb function, bone markers, blood pressure, indicators of the innate immunity system and QOL in post-menopausal Japanese women.
Scientific Title:Acronym
Effect of oral ingestion of Vitamin D3 on lower limb function, bone markers, blood pressure, indicators of the innate immunity system and QOL in post-menopausal Japanese women.
Region
| Japan |
Condition
Condition
None(post-menopausal women)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the trial is to clarify the effect of oral ingestion of vitamin D3 on lower limb function, bone makers, blood pressure, and indicators of innate immunity, and QOL with healthy postmenopausal Japanese women as subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb function:
Knee extension strength
assessment at 16 weeks.
Key secondary outcomes
1. Blood pressure (systolic and diastolic).
2. Bone metabolism index.
3. Inflammatory markers index.
4. Japanese Osteoporosis Quality of Life Questionnaire7)
5. Blood 25(OH)D levels.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of supplement A for 16 weeks
Interventions/Control_2
Ingestion of supplement B for 16 weeks
Interventions/Control_3
Ingestion of plasebo for 16 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1.Healthy postmenopausal women ((No period for 1 year or longer by background questionnaire. FSH >=30 mIU/mL, estradiol (E2)<= 10 pg/mL by screening tests)
2.50 to 69 year of age
3.Serum 25(OH)D level a less-than-or-equal-to 20 ng /mL (50 nmol/L)
4.BMI between 18.5 to 24.9 kg/m2
5.Generally healthy in the opinion of the investigators (based on clinical chemistry and hematology)
6.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.Subjects who are planning to extensively expose one's body to the sun (for example agricultural practice or going on holidays)
3.Serum calcium >2.6 nmol/L
4.Fasting glucose >100 mg /dl
5.Use of HRT within the previous 6 months
moker
6.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
7.Use of Vitamin D supplements
8.Use of high dose Calcium supplements >600 mg
9.Hypertension: higher than 145 / 95 mmHG measured in resting position
10.Treatment for hypertension
11.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
12.Systematic practice of high intensity exercise (high intensity sports more than 3 times per week)
13.Any condition that might interfere with absorption of the investigational product (intestinal malabsorption syndrome, sprue, colitis, gastro-intestinal surgery, M. Whipple)
14.Dieases that carry a risk for hypercalcemia: Sarcoidosis, Tuberculosis, Lymphoma, primary hyperparathyroidism
15.Kidney stones
16.Creatinine clearance of less than 30 ml/min (severe kidney insufficiency)
17.Known hypersensitivity or allergy to dairy or milk products
18.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).
19.Use of any drug which might interfere with bone metabolism (biphosphonate, hormone replacement therapy, estrogen receptor modulators, calcitonin) within the precious 12 months
20.None-fat diets, or other extreme dietary habits
21.Subjects on a weight reduction program or a medically supervised diet
22.Signs of acute or severe illness: unintentional weight-loss, night sweats, treatment for cancer
23.Fracture in the last year or a fall in the last 3 months
24.Alcohol abuse:>=140g /week
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Orimo |
Organization
Kenkoin Clinic
Division name
Director
Zip code
Address
6-7-4Ginza, Chuo-ku, Tokyo,104-0061
TEL
03-3573-1153
nobue-uematsu@kenkoin.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiko Ito |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, 244-0806
TEL
045-820-3972
Homepage URL
itou@fancl.co.jp
Sponsor or person
Institute
Kenkoin Clinic
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
医療法人財団 健康院
健康院クリニック
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 12 | 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 | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2016 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022325
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| Registered date | File name |
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