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The effect of vitamin D on primary dysmenorrhea

Protocol summary

Summary
The aim of this study was to determine the effect of vitamin D supplements on the severity of primary dysmenorrhea in students living in dormitories of Shahid Beheshti University of Medical Sciences. This randomized double-blind controlled clinical trial is conducted on 200 students with inclusion and exclusion criteria. The inclusion criteria the Iranian population are aged between 18-30 years, history of primary dysmenorrhea in 4 recent cycles or 6 months, menstrual cycle 3-7 days, absence of abnormal uterine bleeding , regular menstrual cycles of 22-35 days according to their statements , lack of Pregnancy, having a reading and writing skills , a willingness to participate in the study. Exclusion criteria for secondary dysmenorrhea, unwillingness to continue treatment or take medication, incidence of certain conditions, such as pregnancy, sensitivity, specific and chronic diseases, and forced to intake drug during the study, stressful events such as close families death and surgical procedures. Eligible patients are randomly assigned in to two groups of intervention (capsule of 50,000 units per week or 20,000 units per day vitamin D) and the control group (placebo). The units of the study consume vitamin D capsules two weeks before the menstrual period. And they can use a variety of nonsteroidal anti-inflammatory drugs during treatment, but they should report their type and dose. The study of dysmenorrhea severity by using Multidimensional Scale (Andrich & Millson) Scale before and after treatment in both groups for 4 cycles or 16 weeks, and then the results will analyze by appropriate statistical tests

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201707223860N32
Registration date: 2017-09-16, 1396/06/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-16, 1396/06/25
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences and personal
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D on primary dysmenorrhea
Public title
The effect of vitamin D on women with menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
sex:female؛ age:18-30 years old ؛ experienced primary dysmenorrhea ؛The period of؛ bleeding between 3-7 days؛lack of AUB between bleeding period؛regular cycles with 22-32 days؛Having reading and writing skills؛The desire to participate in the study؛BMI between 18.5-29؛Lack of Pregnancy or Intent in the next three months؛No use of contraceptive methods and IUD
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
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
school of nursing and midwifery,shahid beheshti university of medical science
Street address
valliasr street,Niayeesh crossover,school of nursing and midwifery.shahid beheshti university of medical science
City
Tehran
Postal code
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.772

Health conditions studied

1

Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
Score of early menstrual pain
Timepoint
Before the intervention, the first cycle after the intervention, the second cycle after the intervention
Method of measurement
Visual Scale of Pain

2

Description
Menstrual bleeding
Timepoint
Before the intervention, the first cycle after the intervention, the second cycle after the intervention
Method of measurement
Picture of blood loss

3

Description
Severity of dysmenorrhea
Timepoint
Before the intervention, the first cycle after the intervention, the second cycle after the intervention
Method of measurement
Verbal Multi-dimensional Scoring System (Andrich & Wilson)

Secondary outcomes

1

Description
sedation Consumption
Timepoint
Cycle before intervention, first cycle after intervention, second cycle after intervention
Method of measurement
Cycle before intervention, first cycle after intervention, second cycle after intervention

Intervention groups

1

Description
Interventional group with vitaminD supplements
Category
Treatment - Drugs

2

Description
control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Dormitories of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Rahnemaie
Street address
Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dolatian M
Street address
Valiasr Avenue, Niayesh cross over facing Shahid Rajaee Heart Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti 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
School of nursing and midwifery, shahid beheshti university of medical science
Full name of responsible person
Fatemeh Sadat Rahnemaie
Position
MsC of midwifery
Other areas of specialty/work
Street address
Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (1th floor), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2521
Fax
Email
f_rahnemaie@yahoo.comf_rahnemaie@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Associated Professor of Reproductive health, Department of Midwifery and Reproductive Health, Shahid
Full name of responsible person
Gity Ozgoli
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (1th floor), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2521
Fax
Email
gozgoli@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
school of nursing and midwifery,Shahid Beheshti University of Medical Science
Full name of responsible person
Fatemeh Sadat Rahnemaie
Position
MsC of Midwifery
Other areas of specialty/work
Street address
Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (1th floor), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2521
Fax
Email
f_rahnemaie@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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