1. Home
  2. Approved trials
  3. » فارسی

Evaluation of vitamin C consumption efficacy in prevention of Sudeck atrophy in patients with distal radius fracture

Protocol summary

Summary
Aim of Study: Evaluation of vitamin C efficacy in prevention of Sudeck atrophy a randomized, double-blind, placebo-controlled, single center The study population: Inclusion criteria: People over 18 years with closed distal radial fractures (type 1) Exclusion criteria: Open fractures, closed fractures of type 2 and 3, bilateral fractures, other broken bones and other associated illnesses such as diabetes, neuropathy, and ... Sample:144 Patients In randomized study were given vitamin C to 72 patients and placebo to 72 others patients Intervention time: In fracture days giving vitamin C to 72 cases and placebo to 72 other patients. The patients, respectively, after one week, 4 weeks, 6 weeks (when the plaster is open), once a month, and finally at the end of the six months that is end of clinical trial ended to be reviewed and interviewed. Primary outcome or outcomes studied: Clinical judgment based on 4 or 5 of the following Osteoporosis localized edema, hirsutim or loss of hair area with pain, temperature changes, limiting movement, color changes, hypersensitivity, tremors, involuntary movements, muscle spasms.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013020311898N3
Registration date: 2013-08-04, 1392/05/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Ahmadreza Mirbolouk
Name of organization / entity
Guilin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2250
Email address
ah.mirbolouk@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin C consumption efficacy in prevention of Sudeck atrophy in patients with distal radius fracture
Public title
The effect of vitamin C in preventing Sudeck atrophy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: People over 18 years with closed distal radial fractures (type 1) Exclusion criteria: Open fractures, closed fractures of type 2 and 3, bilateral fractures, other broken bones and other associated illnesses such as diabetes, neuropathy, and ...
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University Of Medical Sciences
Street address
Central Building of Guilan University of Medical Sciences, Opposite the Azodi Stadium, Namjoo Street
City
Rasht
Postal code
Approval date
2012-04-26, 1391/02/07
Ethics committee reference number
1910051501

Health conditions studied

1

Description of health condition studied
sudeck atrophy
ICD-10 code
M89.0
ICD-10 code description
Algoneurodystrophy

Primary outcomes

1

Description
Sudeck atrophy
Timepoint
After one week, 4 weeks, 6 weeks (when the plaster is open), once a month, and finally at the end of the six months
Method of measurement
Clinical judgment based on 4 or 5 of the following Osteoporosis localized edema, hairy or capillary area filled with pain, temperature changes, limiting movement, color changes, hypersensitivity, tremors, involuntary movements, muscle spasms.

Secondary outcomes

empty

Intervention groups

1

Description
fifty 500mg placebo tablets daily
Category
Treatment - Drugs

2

Description
fifty 500mg Vitamin c tablets daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Department, Guilan University of Medical Sciences
Full name of responsible person
Rasoul Tabari (pHD)
Street address
Research and Technology Department, Guilan University of Medical Sciences, opposite of agriculture bank, Gas _ circle
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Research and Technology Department, Guilan University of Medical Sciences
Full name of responsible person
Mohammad sadeq Mousavi
Position
Medical Student
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+1 315552241
Fax
Email
arman.mousavi1989@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ahmadreza Mirbolouk (MD)
Position
Orthopaedic surgeon
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+1 313221572
Fax
Email
mirbolouk@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orthopaedic Research Center,Guilan University of Medical Sciences
Full name of responsible person
Mohammadsadeq Mousavi
Position
Medical Student
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+1 313221572
Fax
Email
arman.mousavi1989@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...