The effect of the combination of vitex agnus castus`s phytoestrogen and magnesium on serum alkaline phosphatase, osteocalcin, angiogenic factor and bone repair in 20-45-year-old wemen with long bone fracture.
The purpose of current study is evaluation the effect of vitex agnus castus`s phytoestrogen and magnesium on serum alkaline phosphatase, osteocalcin, angiogenic factor and callus formation in wemen with traumatic long bone fracture. 64 women aged 20-45 years old with fracture of shaft of long bone were recruited from Chamran hospital. The women were randomly assigned into the four groups to receive vitex agnus castus supplements equal to 3.2-4.8 mg fruit dry extract; Magnesium supplements (250 mg); combination of vitex agnus castus and Magnesium supplements or placebo for 2 months. At baseline and at the end of the second month, biochemical and clinical evaluation will be measured. The primary outcome is increasing the index of alkaline phosphatase, osteocalcin, angiogenic factor and callus formation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092810955N1
Registration date:2012-10-29, 1391/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-29, 1391/08/08
Registrant information
Name
Mohammad Hasan Eftekhari
Name of organization / entity
School of health & nutrition, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1002
Email address
hasanzadez@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the combination of vitex agnus castus`s phytoestrogen and magnesium on serum alkaline phosphatase, osteocalcin, angiogenic factor and bone repair in 20-45-year-old wemen with long bone fracture.
Public title
The effect of the combination of vitex agnus castus`s phytoestrogen and magnesium on fracture healing.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with fracture in long bone (femur, tibia, humerus, radius or ulna); 20-45-year-old. Exclusion criteria: Pregnant or lactating; postmenopausal women; medications for any chronic disease (cancer, diabetes, CVD); use of medication known to affect bone metabolism; use of herbal drug contain phytoestrogen, use of supplements ( multivitamin-minerals,...), diuretics, hormonal drugs; Smoking; Alcohol consumption.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Blvd.
City
Shiraz
Postal code
1978-71345
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
CT-91-6235
Health conditions studied
1
Description of health condition studied
Fracture of shaft of femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
2
Description of health condition studied
Fracture of shaft of tibia
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
3
Description of health condition studied
Fracture of shaft of humerus
ICD-10 code
S42.3
ICD-10 code description
Fracture of shaft of humerus
4
Description of health condition studied
Fracture of shafts of both ulna and radius
ICD-10 code
S52.4
ICD-10 code description
Fracture of shafts of both ulna and radius
Primary outcomes
1
Description
Serum Alkaline phosphatase
Timepoint
Before and 2 months after intervention
Method of measurement
Calorimetry method
2
Description
Serum Osteocalcin
Timepoint
Before and 2 months after intervention
Method of measurement
ELISA kit
3
Description
Serum Vaso Endothelial Growth Factor
Timepoint
Before and 2 months after intervention
Method of measurement
ELISA kit
4
Description
Callus formation
Timepoint
Before and 2 months after intervention
Method of measurement
Radiographic Evidence
Secondary outcomes
empty
Intervention groups
1
Description
vitex agnus castus supplements intake is equivalent to 3.2-4.8 mg fruit dry extract per day, for 2 months
Category
Treatment - Drugs
2
Description
Magnesium supplements, 250 mg magnesium per day, for 2 months
Category
Treatment - Drugs
3
Description
placebo tablet, per day, for 2 months
Category
Placebo
4
Description
vitex agnus castus supplements intake is equivalent to 3.2-4.8 mg fruit dry extract per day, for 2 months and Magnesium supplements, 250 mg magnesium per day, for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital, Shiraz University of Medical Science
Full name of responsible person
Zahra Hasanzadeh Rostami
Street address
School of Health & Nutrition, Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmodini
Street address
Central Medical Building, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Health & Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hasanzadeh Rostami
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Department of nutrition, School of Health & Nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
111-71645
Phone
+98 71 1725 1001
Fax
Email
hasanzadez@sums.ac.ir hassanzadeh_z8@yahoom.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Health & Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hassan Eftekhari
Position
PHD of nutrition, assistant professor of nutrition department, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Department of nutrition, School of Health & Nutrition, Shiraz University of Medical Sciences