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The effect of vitamin D on mammographic breast density in women older than 40 years. years

Protocol summary

Summary
The aim of this study is to determine the effect of vitamin D on mammographic breast density in women older than 40 years.This clinical trials, double-blind, placebo- control, single center study are conducted in Arash Women's Hospital. Among women older than 40 years , 1084 women are randomly participated in this study. Exclusion criteria: Women who have contraindications for consuming vitamin D; history of breast cancer ; Hormonal therapy and oral contraceptives in the last 3 months; Pregnant women; Women who consumed vitamin D supplement in the last 6 months. First, breast density of participants are evaluated with clinical breast examination and were recorded as low or high density. Then the breast density is measured and classified(<25%, 25-50%, 50-70%, >75%)with the bilateral mammography by a radiologist. Then the participants are divided randomly into two groups. Intervention in group 1 include : Tablet vitamin D 50,000 IU, monthly, for 2 years . Intervention in group 2 (placebo group) include: tablet vitamin E 400 IU , monthly , for 2 years. Breast density of all participants are evaluated with breast clinical examination every 6 month and every year with mammography for two years. Finally the rate of beast density are compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904154329N1
Registration date: 2012-09-28, 1391/07/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-28, 1391/07/07
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-16, 1390/08/25
Expected recruitment end date
2015-01-15, 1393/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D on mammographic breast density in women older than 40 years. years
Public title
The effect of vitamin D on breast density in women older than 40 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women older than 40 years who have Indications for mammography. Exclusion criteria: Women who have contraindications for consuming vitamin D; History of breast cancer; Hormonal therapy and oral contraceptives in the last 3 months; Pregnant women; Women who consumed vitamin D supplement in the last 6 months.
Age
From 41 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1084
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
Tehran University of Medical Sciences ,Deputy of Research.
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-11-16, 1390/08/25
Ethics committee reference number
10530

Health conditions studied

1

Description of health condition studied
Breast density
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
The rate of breast density
Timepoint
Every 6 months with clinical examination and every year with mammography for 2 years
Method of measurement
Mammography , Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Groups: Tablet vitamin D ( 50,000 IU), monthly for 2 years.
Category
Treatment - Drugs

2

Description
Control Groups: Tablet vitamin E ( 400 IU), monthly ,for 2 years.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women 's Hospital
Full name of responsible person
Sadaf Alipour,Assistant Professor of Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
D.r Akbar Fotohi
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences , Deputy of Research
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
Arash Women 's Hospital,Tehran University of Medical Sciences
Full name of responsible person
D.r Sadaf Alipour
Position
Assistant Professor of Surgery
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran
Postal code
1653915981
Phone
+98 21777719922
Fax
Email
salipour@Sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
D.r Sadaf Alipour
Position
Assistant Professor of Surgery
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
Ladan Hosseini
Position
MS , Employee of research development center
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
hosseiniladan@yahoo.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
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