Protocol summary

Study aim
Determination of vitamin D supplementation on inflammatory markers (IL-10, IL-12), antioxidant (TAC), and physique and mood syndrome of students with premenstrual syndrome (PMS) and vitamin D deficiency
Design
Double-blind randomized clinical trial with parallel control group
Settings and conduct
The subjects from among 18-25 year-old female students with premenstrual syndrome and vitamin D deficiency in Isfahan University of medical sciences who have criteria for entering the study will be selected through multistage random cluster sampling
Participants/Inclusion and exclusion criteria
Aged 18-25 years, having normal BMI, single, serum vitamin D levels of 10-30 ng / ml, regular menstrual cycle with intervals of 21-35 days, lack of depression and anxiety, lack of diseases Acute and chronic, lack of iron deficiency anemia (anemia), lack of exercise on a regular basis, no use of combined tablets containing estrogens and progesterone , Lack of vitamin D supplementation in the past 3 months, the student does not start or finish the term in the semester
Intervention groups
During the four menstrual cycles, every two weeks, the intervention group receives an oral supplement of 50,000 units of vitamin D and the control group receiving a placebo that looks like vitamin D supplementation. People are asked to complete the PMS daily registration form during the last 2 additional cycles of supplemental supplementation. The amount of vitamin D intake will be collected through the Frequency Frequency Questionnaire. The levels of vitamin D, inflammatory markers and antioxidant in luteal phase and anthropometric information (weight, height, BMI and waist circumference) will be measured before and after intervention.
Main outcome variables
Levels of Interleukin 10 and 12 and total antioxidant capacity; Physical and psychological Symptoms of syndrome

General information

Reason for update
Acronym
PMS
IRCT registration information
IRCT registration number: IRCT20180525039822N1
Registration date: 2018-06-20, 1397/03/30
Registration timing: retrospective

Last update: 2018-06-20, 1397/03/30
Update count: 0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Hajar Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3324 3712
Email address
h.heidari72@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-12-31, 1396/10/10
Actual recruitment end date
2018-02-02, 1396/11/13
Trial completion date
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Scientific title
The effect of vitamin D supplementation on inflammation and antioxidant markers and premenstrual syndrome(PMS) symptoms in vitamin D- deficient students
Public title
The effect of vitamin D supplementation on premenstrual syndrome(PMS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25-18 years BMI in normal range single Serum vitamin D level is 30- 10 ng / ml Having a regular menstrual cycle with intervals of 35 to 21 days Not doing regular exercise Students do not start or finish their studies in the semester
Exclusion criteria:
Acute and chronic diseases such as: cardiovascular, kidney, liver, diabetes, hypothyroidism, hyperthyroidism and asthma Iron deficiency anemia (Anemia) Depression and anxiety Consumption of combined pills containing estrogen and progesterone Take supplemental vitamin D in the last 3 months
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 44
Actual sample size reached: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage cluster randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness will be that the supplementation of vitamin D and placebo will not be communicated to anyone by someone outside the research team and team members such as a researcher, clinical care provider, and supplementary participants
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.MUI.REC.1395.3.734

Health conditions studied

1

Description of health condition studied
premenstrual syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum level of interleukin 10 based on ELISA method
Timepoint
At the beginning of the study and after 4 months of intervention
Method of measurement
Blood sampling and serum level determination using ELISA kit

2

Description
Serum level of interleukin 12 based on ELISA method
Timepoint
At the beginning of the study and after 4 months of intervention
Method of measurement
Blood sampling and serum level determination using ELISA kit

3

Description
Serum level of total antioxidant capacity based on ELISA method
Timepoint
At the beginning of the study and after 4 months of intervention
Method of measurement
Blood sampling and serum level determination using ELISA kit

4

Description
Score of physical symptoms and mood syndrome in premenstrual syndrome in the symptom registration questionnaire
Timepoint
At the beginning of the study and after 4 months of intervention
Method of measurement
Premenstrual Signs Indexing Questionnaire (DSM-IV)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: An oral supplement of 50,000 units of vitamin D from Tabriz's Zahrawi Company during 4 menstrual cycles every two weeks
Category
Treatment - Drugs

2

Description
Control group: Receiving a placebo that looks similar to vitamin D supplementation.Tabriz Zahravi company, it is administered every four weeks in 4 cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
دانشگاه علوم پزشکی اصفهان
Full name of responsible person
Reza Amani
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
h.heidari72@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Heidari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4262 5779
Email
h.heidari72@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Heidari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4262 5779
Email
h.heidari72@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Heidari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4262 5779
Email
h.heidari72@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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