The effects of calcium and vitamin B1 supplementation on premenstrual syndrome (PMS) in female university students: A randomized clinical controlled trial
The aim of the study is to determine the effects of calcium and vitamin B1 supplementation on premenstrual syndrome (PMS) in female university students. The study is a double-blind placebo-controlled randomized clinical trial and subjects are 200 female students of Ilam University of Medical Sciences. Students who experience at least 3 symptoms of PMS questionnaire’s criteria with moderate and severe intensity during 3 consecutive period cycles and also who have at least 5 signs of the DMS-IV criteria for premenstrual dysphoric disorder (PMDD) will be recruited. The age range of 18 to 30 years and having regular menstruation cycle with 24 to 35 days intervals are among another inclusion criteria. Exclusion criteria include having any history of physical and mental illnesses; consuming any drugs such as anti-convulsants and anti-depressants; consuming multivitamin, vitamin B1 and calcium supplements during last 3 months. The intervention duration is 2 months and subjects will randomly assigned into 4 groups of 54 students as follow: group1: receiving one tablet of 500 mg calcium carbonate per day; group 2: receiving one tablet of 100 mg vitamin B1 per day; group 3: receiving one tablet of 500 mg calcium carbonate and one tablet of 100 mg vitamin B1 per day; group 4: receiving one placebo tablet containing 1 mg of starch powder per day. Primary outcome of the study is the change in the score of the PMS’ questionnaire and secondary outcome is the change in the score of the PMDD’s questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011810333N3
Registration date:2016-02-13, 1394/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-13, 1394/11/24
Registrant information
Name
Nasrin Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 0608
Email address
sharifi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of calcium and vitamin B1 supplementation on premenstrual syndrome (PMS) in female university students: A randomized clinical controlled trial
Public title
The effects of calcium and vitamin B1 supplementations on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age ranges of 18 to 30 years; having body mass index between 18.5 to 30 kg/m2; having regular menstrual cycle with 24 to 35 days interval; experiencing at least 3 symptoms of PMS questionnaire’s criteria with moderate and severe intensity during 3 consecutive period cycles; having at least 5 signs of the DMS-IV criteria for premenstrual dysphoric disorder
Exclusion criteria: having any history of physical and mental illnesses; consuming anti-convulsants; consuming anti-depressants; consuming hormones and oral contraceptives; consuming multivitamin, vitamin B1 and calcium supplements during last 3 months.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Pajoohesh Blvd.
City
Ilam
Postal code
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
IR.MEDILAM.REC.1394.88
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Changes in scores of premenstrual syndrome's questionnaire
Timepoint
Before and 2 months after the start of the intervention
Method of measurement
Standard questionnaire for premenstrual syndrome
Secondary outcomes
1
Description
Changes in scores of the premenstrual dysphoric disorder's questionnaire
Timepoint
Before and 2 months after the start of the intervention
Method of measurement
Standard questionnaire for premenstrual dysphoric disorder
Intervention groups
1
Description
Intervention: Tablet contains 500 mg calcium carbonate and tablet contain 100 mg vitamin B1, each once a day for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention: Tablet contains 100 mg vitamin B1, once a day for 8 weeks
Category
Treatment - Drugs
3
Description
Control: Tablet contains 1 mg starch powder, once a day for 8 weeks
Category
Treatment - Drugs
4
Description
Intervention: Tablet contains 500 mg calcium carbonate, once a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ilam University of Medical Sciences
Full name of responsible person
Dr. Sepeedeh Zahra Farhang
Street address
Ilam University of Medical Sciences, Pajoohesh Blvd.
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Behzad Badakhsh
Street address
Vice Chancellor for Research and Technology, Ilam University of Medical Sciences
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Soheila Samieepour
Position
MSc of Food Sciences and Technology
Other areas of specialty/work
Street address
Paramedical School, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 88432232523
Fax
Email
sarma1364@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Samieepour
Position
MSc of Food Sciences and Technology
Other areas of specialty/work
Street address
Paramedical School. Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 88432232523
Fax
Email
sarma1364@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Samieepour
Position
MSc
Other areas of specialty/work
Street address
Paramedical School, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 31 5554 0021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)