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IRCT20180218038789N3 IRCT 2020-09-15 Qazvin University of Medical Sciences Effect of vitamin D on intensity of dysmenorrhea Investigating the effect of low dose vitamin D on intensity of dysmenorrhea 2020-10-22 anticipated 92 Complete https://irct.ir/trial/50812 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Primary dysmenorrhea. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Participants' personal data is shared in an unidentifiable manner along with the publication of the final article When: After the completion of study To whom: there is no limitation Conditions: there is no limitation Where to obtain: Email to corresponding author How to obtain: Specify the purpose of the need to access the data Comments:
public Zainab Alimoradi
Bahonar Bulevard, Qazvin University of Medical Sciences
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6002 zainabalimoradi.sbmu.ac.ir@gmail.com Qazvin University of Medical Sciences scientific Zainab Alimoradi
Bahonar Bulevard, Qazvin University of Medical Sciences
Qazvin Iran (Islamic Republic of) 3419759811 0098283336002 zainabalimoradi.sbmu.ac.ir@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 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 18 years 35 years Female 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 N94.4 Primary dysmenorrhea Prevention Placebo 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. 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. Intensity of dysmenorrhea pain. Timepoint: Before, Immediately, 1, 3, 6 months after intervention. Method of measurement: Visual analogue scale. 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. 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. Menstrual distress. Timepoint: Before, immediately, 1, 3 and 6 months after the intervention. Method of measurement: Moos questionnaire of menstrual distress. Qazvin University of Medical Sciences Approved 2020-05-17 Ethics committee of Qazvin University of Medical Sciences Bahonar Bulevard, Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)