Effect of vitamin D supplementation on serum 25-hydroxyvitamin D levels, inflammatory biomarkers and total antioxidant capacity in different types of vitamin D receptor polymorphisms in breast cancer women
This study has been designed to evaluate the Effect of vitamin D supplementation on serum 25-hydroxyvitamin D levels, biomarkers of inflammation and total antioxidant capacity in different types of vitamin D receptor polymorphisms in breast cancer women. This study will be done as a double blind controlled randomized trial with a period of 8 weeks. Forty six subjects with cancer will be selected from Ahvaz Shafa Hospital. Inclusion Criteria are included all women who were diagnosed with stage ɪ breast cancer; age>20; 23< BMI<30; not consuming any kinds of vitamin D supplements during last 3 months. Exclusion criteria are included a history of any types of cancer; people with chronic diarrhea and malabsorption; non-Iranian races. The subjects will be divided into 2 groups based on randomized block design. Group 1 will receive 50000 IU of vitamin D3 per week, group 2 will receive placebo per week. Serum levels of TNF-α, TGF-β, TAC and 25 (OH) D will be determine by taking blood samples at the baseline and at the end of the intervention. VDR gene polymorphisms (FOK1, Bsml1, Taq and Apa1) will be determined by SSP-PCR techniques. Anthropometric measurements (height, weight and waist circumferences) will be measured at the baseline and after 8 weeks of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090623924N1
Registration date:2015-10-08, 1394/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-08, 1394/07/16
Registrant information
Name
houra mohseni
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33367543
Email address
mohseni.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on serum 25-hydroxyvitamin D levels, inflammatory biomarkers and total antioxidant capacity in different types of vitamin D receptor polymorphisms in breast cancer women
Public title
Effect of vitamin D supplementation on serum 25-hydroxyvitamin D levels, inflammatory biomarkers and total antioxidant capacity in different types of vitamin D receptor polymorphisms in breast cancer women
Purpose
Treatment
Inclusion/Exclusion criteria
all women who were diagnosed with stage ɪ breast cancer; age>20 years; 23< BMI<30; not consuming any kinds of vitamin D supplements during last 3 month; not getting any medication that affect serum vitamin D status. Exclusion criteria: the presence of any underlying disease (liver, kidney and HIV); a history of chemotherapy or radiotherapy for any reason except for current cancer; treatment with Corticosteroids; pregnancy and lactation; chronic diarrhea and malabsorption; non-iranian races (foreigners).
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Highway, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
15794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
Ir.ajums.rec.1394.253
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Tumor Necrosis Factor alpha
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA
2
Description
Transforming Growth Factor beta
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA
3
Description
Total Antioxidant Capacity
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA
4
Description
25 (OH) D
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA
5
Description
vitamin D receptor polymorphisms (FOK1، Bsml1، Taqو Apa1)
Timepoint
At the beginning of the study
Method of measurement
PCR
Secondary outcomes
1
Description
Antropometric Measurments (height, weight and waist circumferences)
Timepoint
at the baseline and after 8 weeks of intervention
Method of measurement
Height, hip and waist circumferences in cm and weight in kg by standard method
Intervention groups
1
Description
Placebo, one time per week for 2 months
Category
Placebo
2
Description
Vitamin D, 50,000 IU, one time per week for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Houra Mohseni, student of Master Science
Street address
Golestan, Shafa Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
DR. Ghadiri
Street address
Ahvaz, Golestan Highway, Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Houra Mohseni
Position
Student of Master Science
Other areas of specialty/work
Street address
School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
houra.mohseni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Amani
Position
Professor of Nutrition Science
Other areas of specialty/work
Street address
School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Rezaamani@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Houra Mohseni
Position
Student of Master Science
Other areas of specialty/work
Street address
City
Ahvaz
Postal code
Phone
00
Fax
Email
houra.mohseni@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)