UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012821 |
|---|---|
| Receipt number | R000014970 |
| Scientific Title | Effect of nandrolone, calcium-D and vitamin C on fracture union |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2014/01/11 00:38:21 |
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Basic information
Public title
Effect of nandrolone, calcium-D and vitamin C on fracture union
Acronym
Effect of nandrolone, calcium-D and vitamin C on fracture union
Scientific Title
Effect of nandrolone, calcium-D and vitamin C on fracture union
Scientific Title:Acronym
Effect of nandrolone, calcium-D and vitamin C on fracture union
Region
| Asia(except Japan) |
Condition
Condition
fracture of tibia and fibula
Classification by specialty
| Medicine in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to observe if nandrolone, calcium and vitamin C has positive effect on healing of fracture of bone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
effect of nandrolone, calcium and vitamin C on healing of fractured bone
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nandrolon
Interventions/Control_2
Calcium + Vitamin D
Interventions/Control_3
Vitamin C
Interventions/Control_4
no drug or supplement
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
any male patients with fracture of the shaft of tibia and fibule in 18 - 50 years old range
Key exclusion criteria
Open fractures
Pathologic fractures
Previous fracture in the bones
Multiple fractures in the same or other extremities
Multiple trauma patients with head or abdomen or other organ injuries
Diabetes mellitus or other chronic disorders such as rheumatoid arthritis
Metaphyseal or intraarticular fractures or any fracture patterns that could not fix with closed intramedullary nailing method
Any indication for fixation of fibula in addition to tibia
Addiction to any drugs or narcotics
Any contraindication to use nandrolone, calcium and vitamin C
Target sample size
139
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Alii Yeganeh |
Organization
Iran University of Medical Science
Division name
Orthopedics
Zip code
Address
Hemmat highway
TEL
+81-0989122187996
yeganeh471@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Afshin Ahmadzadeh Heshmati |
Organization
Kerman University of Medical Science
Division name
Orthopedics
Zip code
Address
Jomhoori eslami BLVD
TEL
+81-0983412810061
Homepage URL
aahorthoped@gmail.com
Sponsor or person
Institute
No Sponsor
Institute
Department
Personal name
Funding Source
Organization
No funding from any organization
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
| 2014 | Year | 02 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 11 | Day |
Last modified on
| 2014 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
