Protocol summary

Study aim
Determining the intensity of dysmenorrhea pain in the two intervention and control groups before, immediately, 1, 3 and 6 months after the intervention
Design
Double Blind Randomized Placebo Controlled Trial
Settings and conduct
Participants will be recruited via convenience sampling by referring to different faculties of Qazvin University of Medical Sciences. eligible people with the desire to participate in the study are registered. Then random allocation in two groups will be done by balanced block randomization method with block size of 4. Participants, researchers, outcome assessors, and data analysts will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Moderate to severe primary dysmenorrhea (score higher than 4 based on visual pain scale) 2. Single 3. At reproductive ages (18 to 35 years) 4. Student of Qarvin University of Medical Sciences 5. Willingness to participate in the study Exclusion criteria: 1. Existence of secondary dysmenorrhea and its predisposing factors such as history of endometriosis, adenomyosis, subacute endometritis, pelvic inflammatory disease, copper intrauterine devices, ovarian cysts, congenital pelvic malformations and cervical stenosis based on individual statement. 2. History of known mental illness based on individual statement 3. Drug addiction based on a person's statement 4. Probability of graduation during the follow-up period 5. Use vitamin D or calcium supplements 6. Concomitant use of corticosteroids, anticonvulsants, anti-tuberculosis, anti-hypertensive drugs that interfere with the absorption of vitamin D
Intervention groups
Intervention group with vitamin capsule 1000 units / control group with placebo capsule
Main outcome variables
Intensity of dysmenorrhea pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180218038789N3
Registration date: 2020-09-15, 1399/06/25
Registration timing: prospective

Last update: 2020-09-15, 1399/06/25
Update count: 0
Registration date
2020-09-15, 1399/06/25
Registrant information
Name
Zainab Alimoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6003
Email address
z.alimoradi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of low dose vitamin D on intensity of dysmenorrhea
Public title
Effect of vitamin D on intensity of dysmenorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe primary dysmenorrhea (score above 4 based on visual pain scale) Being Single Being at reproductive ages (18 to 35 years) Student of Qazvin University of Medical Sciences Willingness to participate in the study
Exclusion criteria:
Presence of secondary dysmenorrhea and its underlying factors such as history of endometriosis, adenomyosis, subacute endometritis, pelvic inflammatory disease, copper intrauterine devices, ovarian cysts, congenital pelvic malformations and cervical stenosis based on individual statement Concurrent use of corticosteroids, anticonvulsants, anti-TB, anti-hypertension, which interfere with the absorption of vitamin D. Use vitamin D or calcium supplements Probability of graduation during the follow-up period History of known mental illness based on individual statement Drug addiction based on self disclosure
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be assigned to intervention groups and placebo by block randomization method using 4 blocks. Given that the two groups will be studied, blocks with size of 4 are used and each letter is assigned to a group (A: intervention group, B: comparison group). All possible modes are written and numbered for a block of 4, such as: 1.AABB 2.ABAB 3.BBAA 4.BABA 5.ABBA 6.BAAB 7 .--- Then, in a simple random method (using a table of random numbers), a number of numbers are selected from the block numbers and by writing the contents of the blocks related to those numbers (until the specified sample size is obtained), The random assignment sequence is specified. For example, if the numbers obtained are 3, 2, 2, 1, etc., respectively, the assignment sequence will be as follows: AABB ABAB ABAB BBAAThe type of intervention is then written based on the allocation sequence and placed in envelopes in a matte package. The envelopes are coded in order. In this case, for the person who receives the intervention code 1, a questionnaire with the same code is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding of medicine and placebo capsules will be done by the pharmaceutical company. The drug and placebo will be similar in shape, color and smell and will be provided to the researcher with the code a, b. The participant, researcher, outcome assessor, and data analyst will be unaware of the codes until the end of the analysis. At the end of the analysis, codes specific to each group will be taken from the pharmaceutical company.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.QUMS.REC.1399.033

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
Intensity of dysmenorrhea pain
Timepoint
Before, Immediately, 1, 3, 6 months after intervention
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Duration of dysmenorrhea pain
Timepoint
Before, immediately, 1, 3 and 6 months after the intervention
Method of measurement
Individual report of pain duration by day

2

Description
Need to use pain killer
Timepoint
Before, immediately, 1, 3 and 6 months after the intervention
Method of measurement
Individual report of need to use pain killer

3

Description
Menstrual distress
Timepoint
Before, immediately, 1, 3 and 6 months after the intervention
Method of measurement
Moos questionnaire of menstrual distress

Intervention groups

1

Description
Intervention group: Capsule of Vitamin D 1000 IU// These capsules will be provided by Nanohiat Pharmaceutical Company. Vitamin D capsules with a dose of 1000 units are prepared for daily use. The intervention plan is to prescribe one capsule daily for two consecutive months. Each eligible participant is asked to start taking the capsules when menstrual bleeding begins and to take one capsule daily for two months after the initial assessments.
Category
Prevention

2

Description
Control group: Placebo capsule// These capsules will be provided by the same company in exactly the same way as the capsules containing the drug in terms of size, shape and color. The intervention plan is to prescribe one capsule daily for two consecutive months. Each eligible participant, after initial assessments, is asked to start taking the capsules when menstrual bleeding begins and to take one capsule daily for two months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculties of Qazvin University ogf a
Full name of responsible person
Zainab Alimoradi
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6002
Email
zainabalimoradi.sbmu.ac.ir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Emam Jomeh
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6002
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6002
Email
zainabalimoradi.sbmu.ac.ir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
0098283336002
Email
zainabalimoradi.sbmu.ac.ir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimmoradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Bulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6002
Email
zainabalimoradi.sbmu.ac.ir@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
Not applicable
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
Participants' personal data is shared in an unidentifiable manner along with the publication of the final article
When the data will become available and for how long
After the completion of study
To whom data/document is available
there is no limitation
Under which criteria data/document could be used
there is no limitation
From where data/document is obtainable
Email to corresponding author
What processes are involved for a request to access data/document
Specify the purpose of the need to access the data
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