Investigating the effect of zinc use on medical students living in the dormitories of Shahid Beheshti University of Medical Sciences with premenstrual syndrome in the Faculty of Medicine
Determining the effect of zinc supplementation on psychological and physical symptoms caused by premenstrual syndrome
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 200 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this study, we intend to measure the effect of zinc use on psychological and somatic symptoms of premenstrual syndrome in a randomized and double-blind clinical trial. For this purpose, first, 200 interns and interns of Shahid Beheshti University of Medical Sciences, who are single and live in the student dormitory, are randomly called to participate in the study.
Participants/Inclusion and exclusion criteria
Age between 20-35 years / history of regular menses (at least in the last 6 months each cycle 21-35 days and the amount of bleeding is not severe and it has been bleeding for less than 7 days) / BMI between 19.8 to 26/ diagnosis of premenstrual syndrome based on PSST questionnaire
People who have any chronic disease or psychiatric disease caused by severe PMS, receive psychiatric drugs, hormones,
Supplements at the time of study or 6 months before, smokers and vegetarian diet, suspected pregnancy, desire to
Those who are pregnant or currently breastfeeding will not be included in the study
Intervention groups
The use of 220 mg zinc gluconate tablets in the intervention group and placebo in the control group
Main outcome variables
Psychological and physical symptoms caused by premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221127056632N1
Registration date:2023-02-05, 1401/11/16
Registration timing:prospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Samira Zallaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 5547
Email address
samira.z1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of zinc use on medical students living in the dormitories of Shahid Beheshti University of Medical Sciences with premenstrual syndrome in the Faculty of Medicine
Public title
Zinc supplemnt in premenstruation syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-35 years
History of regular menses at least in the last 6 months (each cycle lasts 21-35 days and the amount of bleeding is not severe and has less than 7 days of bleeding)
Body mass index between 19.8 and 26
Diagnosis of premenstrual syndrome based on PSST questionnaire
Exclusion criteria:
Any chronic illness or psychiatric illness caused by severe PMS
Receiving hormonal psychiatric drugs, supplements at the time of the study or 6 months before
Smokers and vegetarians
Suspected pregnancy, desire to become pregnant, current breastfeeding
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual
In this way, after collecting the initial questionnaires, by a person outside the study, the owner of each questionnaire is assigned a 4-digit code that starts from 1000 consecutively. Then people with an even code enter the control group with placebo and people with an odd code enter the group supplemented with zinc.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind and the participants and the researcher who dispenses the drug do not know who belongs to the control or intervention group. In this study, with the coordination of the pharmaceutical company, the placebo and the drug have been tried to be completely similar.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
shahid beheshti medical university, koodakiar Ave., Arabi street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-11-29, 1401/09/08
Ethics committee reference number
IR.SBMU.MSP.REC.1401.439
Health conditions studied
1
Description of health condition studied
Premenstrual tension syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Physical and psychological symptoms of premenstrual syndrome
Timepoint
At the beginning of the study (when sampling and before the start of the intervention) and 3 months after the start of the intervention
Method of measurement
Premenstrual Symptoms Screening Tool questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Zinc supplement users-These people are 100 people who were randomly selected and will be treated with oral zinc supplements (produced by RouaDaru pharmaceutical company and with a dose of 30 mg) for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: placebo users-According to our order to Roz Daru Company, similar to supplement pills
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdie Hospital
Full name of responsible person
Samira Zalaghi
Street address
Shush Square - Fedayian Islam St. - Shishagar Khane Alley - Shahid Rajab Nia St
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zaraghi
Street address
Shahid beheshti medical university, Koodakiar Ave, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Zallaghi
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr street, before Tajrish square, Sarshar avenue, No12
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 5506 5547
Fax
Email
samira.z1399@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Zallaghi
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr street, before Tajrish square, Sarshar avenue, No12
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 5506 5547
Fax
Email
samira.z1399@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Zalaghi
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr street, before Tajrish square, Sarshar avenue, No12
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
samira.z1399@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information related to the main outcome, including the PSST test score, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All researchers working in academic, scientific and industrial institutions can apply to receive information.
Under which criteria data/document could be used
The data of this study can be used for systematic review studies and meta-analysis after the publication of the article.
From where data/document is obtainable
Applicants need to send an email to the main organizer of the project at samira.z1399@gmail.com in English.
What processes are involved for a request to access data/document
After sending an email in English to the above address, the applicant can access the data after two working weeks.