Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000445370
Ethics application status
Approved
Date submitted
22/02/2017
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of vitamin D on bone and muscle density in myasthenia gravis patients
Scientific title
Effects of vitamin D on bone and muscle density in myasthenia gravis patients
Secondary ID [1] 291251 0
RD105079
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myasthenia gravis 302180 0
Condition category
Condition code
Inflammatory and Immune System 301792 301792 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vit D 3 administration
a) the dose administered:2 drops once daily (400 iu/drop)
b) the duration of administration:12 weeks
c) the mode of administration:oral drop
Intervention code [1] 297255 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 301193 0
Change in bone muscle density using the Dual energy X-ray absorptiometry (Hologic Explorer series)
Timepoint [1] 301193 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [1] 331992 0
Change in meridian analysis using the Meridian Electroacupuncture Analysis Device, MEAD the 6th generation, Medpex Enterprises, Taiwan
Timepoint [1] 331992 0
Baseline, and at 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
myasthenia gravis patients
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, mental disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8685 0
Taiwan, Province Of China
State/province [1] 8685 0

Funding & Sponsors
Funding source category [1] 295703 0
Hospital
Name [1] 295703 0
Show Chwan Memorial Hospital
Country [1] 295703 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Show Chwan Memorial Hospital
Address
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 294544 0
None
Name [1] 294544 0
Address [1] 294544 0
Country [1] 294544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297009 0
Institutional Review Board of Show Chwan Memorial Hospital
Ethics committee address [1] 297009 0
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Ethics committee country [1] 297009 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297009 0
Approval date [1] 297009 0
29/12/2016
Ethics approval number [1] 297009 0
1050704

Summary
Brief summary
The expected outcomes will demonstrate the effects after supplement of vitamin D by ages and genders of MG patients with in-depth understanding integrating dietitian, radiologist, pharmacist, respiratory therapist, and clinical psychologist. This multidimensional project will provide empirical evidence to clinical specialists related to the demands and effects of the supplementation of vitamin D for MG patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72706 0
Dr Chun-Yi Lin
Address 72706 0
Department of Nuclear Medicine, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 72706 0
Taiwan, Province Of China
Phone 72706 0
+886 975611183
Fax 72706 0
Email 72706 0
[email protected]
Contact person for public queries
Name 72707 0
Mrs Chen-Chen Wang
Address 72707 0
Research Assistant Center, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 72707 0
Taiwan, Province Of China
Phone 72707 0
+886 975611854
Fax 72707 0
Email 72707 0
[email protected]
Contact person for scientific queries
Name 72708 0
Mr Ming-Tsung Lee
Address 72708 0
Research Assistant Center, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 72708 0
Taiwan, Province Of China
Phone 72708 0
+886 975611502
Fax 72708 0
Email 72708 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.