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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019304
Receipt No. 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

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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
Email 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
Email itou@fancl.co.jp

Sponsor
Institute Kenkoin Clinic
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)

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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