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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003925
Receipt No. 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

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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
Email

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
Email ma_hara_h@hotmail.com

Sponsor
Institute Department of Orthopaedic Surgery, Kurihara Central Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004718

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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