UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003925 |
|---|---|
| Receipt number | R000004718 |
| Scientific Title | Effect of Vitamin D3 Supplementation on Back Muscle Strength Gainged by Back Muscle Exercise |
| Date of disclosure of the study information | 2010/07/19 |
| Last modified on | 2013/01/25 16:35:09 |
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Basic information
Public title
Effect of Vitamin D3 Supplementation on Back Muscle Strength Gainged by Back Muscle Exercise
Acronym
Effect of Vitamin D3 Supplementation on Back Muscle Strength
Scientific Title
Effect of Vitamin D3 Supplementation on Back Muscle Strength Gainged by Back Muscle Exercise
Scientific Title:Acronym
Effect of Vitamin D3 Supplementation on Back Muscle Strength
Region
| Japan |
Condition
Condition
post-menopausal women
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of vitamin D3 supplementation on the effect of muscle exercise is still unknown. To determine the additive effect of vitamin D3 on the back muscle strength gained by the back muscle exercise, we performed clinical trial in the post-menopausal osteoporotic women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At baseline and afrer four months of follow up,the following assessments are done.
Physical examination:Height,Weight,BMI, Finger-Floor-Distance,Grip power,Heart rate
Serium: 1,25(OH)D3,25(OH)D,Ca,P,BUN,creatinin
Urine:Ca,P,NTX
Fall:It records to the diary.
Spinal curvature:Thoracic kyphosis, Lumber lordosis, Sacral inclination, Spinal ROM
Bone mineral density: Spine(L2-4)(g/cm2)
QOL total score: The Japanese osteoporosis QOL questionnaire(JOQOL) 2000 is used.
Statistical analysis: Statistical analysis is done by using Repeated measures ANOVA(GraphPad Prism v. 5) between the control group and the D3 group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
D3 groups were treated with daily calcium(200mg/day,orally), weekly alendronate(35mg/week,orally) and the back muscle exercise whereas daily alphacalcidol(1.0microg/day,orally) was added in this group.
Exercise was done in prone position with a pillow under the abdomen.They were instructed to lift their upper trunk toward the neutral positon for 5 seconds,10 per sessition,1session per day.
Interventions/Control_2
Control groups were treated with daily calcium(200mg/day,orally), weekly alendronate(35mg/week,orally) and the back muscle exercise.
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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Japanese osteoporotic women aged from 55 to 75
2.Diagnosis for osteoporosis was based on the criteria from the Japanese Society for Bone and Mineral Reserch.
Key exclusion criteria
1.More than three vertebral fractures in thoracic and lumbar spine
2.Who unable to do daily back muscle exercise
3.Treated with vitamin D within 6 months.
4.Secondary osteoporosisi
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Hara |
Organization
Wakayanagi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
Tukidatemiyanotyuuou Kurihara 3-1-1 Miyagi 987-2203 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurihara Central Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
ma_hara_h@hotmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kurihara Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2010 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 18 | Day |
Last modified on
| 2013 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004718
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| Registered date | File name |
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| Registered date | File name |
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