The aims of the present study are to examine the effect of vitamin D supplementation on intensity of cyclical breast pain and prolactin level. This clinical trial is conducted on 80 women suffering from cyclical mastalgia. They are randomly (through block randomization) allocated into the two study groups of vitamin D and placebo. The data collectors and participants will be kept blind to group allocation to create a double blind trial. This study will be conducted in the three centers affiliated to Shiraz University of Medical Sciences. The inclusion criteria include: having mastalgia for at least 5 days per menstrual cycle, vitamin D level between 10-30 Nano gram per milliliter, without any severe somatic or psychological disease, and no history of breast cancer. The vitamin D group will receive 2000 International Unit (IU) vitamin D per day for 8 weeks, whereas the control group will receive placebo. All women with serum vitamin D less than 10 ng/ml (severe deficiency) will receive 2000 IU vitamin D per day for 8 weeks. Their before and after intervention data will be compared at the end of the study. Stressful life events such as a family member death or starting a new program such as an exercise program or a new diet in daily life will lead to drop out from the study. The intensity of breast pain is measured before and after intervention in all participants by visual analogue scale (VAS). Also, vitamin D and prolactin levels will be measured two times, before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072610327N16
Registration date:2017-08-26, 1396/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Vitamin D supplementation on pain and serum level of prolactin in women suffering from cyclical mastalgia
Public title
Vitamin D supplementation effect on cyclical mastalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 18 years of age; serum level of vitamin D 10- 30 ng/ ml; breast pain duration of ≥5 days per menstrual cycle; without any somatic or psychological disease.
Exclusion criteria : Pregnant or lactating women; history of breast cancer; Stressful life events such as death of a family member.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The block randomization method is designed to randomize subjects into study groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.SUMS.REC.1396.31
Health conditions studied
1
Description of health condition studied
Cyclical mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
Primary outcomes
1
Description
Intensity of mastalgia
Timepoint
before and after intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
Serum level of prolactin
Timepoint
before and after intervention
Method of measurement
Lab test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive 2000 IU of oral vitamin D per day for 8 weeks.
Category
N/A
2
Description
Control group: The control group will receive placebo for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast clinic in Motahari medical center
Full name of responsible person
Soheila Shafieian
Street address
Nemazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand street
City
Shiraz
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
MS degree
Other areas of specialty/work
Street address
Nursing and Midwifery school, Nemazi square, Zand street
City
Shiraz
Postal code
Phone
+98 71136281497
Fax
008871136474252
Email
roose82003@yahoo.com; vazirif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hoseien Dabbaghmanesh
Position
Endocrinologist
Other areas of specialty/work
Street address
Densitometry center, Nemazi hospital,Zand street
City
Shiraz
Postal code
Phone
+98 71136281497
Fax
+98 71136474252
Email
dabbaghm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
MS degree
Other areas of specialty/work
Street address
Nursing and Midwifery school, Nemazi square, Zand street
City
Shiraz
Postal code
Phone
+98 71136474252
Fax
+98 71136474252
Email
vazirif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)