]>
IRCT20250226064862N1 IRCT 2025-07-01 Torbate-Heidaria University of Medical Sciences Effect of calcium and vitamin B1 on the severity of menstrual distress Comparison of the effects of calcium and vitamin B1 on the severity of menstrual distress in 18-26 year old girls residing in dormitories 2024-08-22 anticipated 150 Complete https://irct.ir/trial/82166 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the research units were individually and randomly assigned to three groups: calcium consumers, vitamin B1 consumers, and control. After preparing a list of research units with inclusion criteria, Excel software was used for randomization, and the randomization was completely hidden and based on the number of research units. For this purpose, all research units that met the inclusion criteria were assigned a number, which, based on the expected required sample size, created a total numerical range between 1 and 150. Then, the RANDARRY function in Excel was used to select random data without repetition in the three study groups, Blinding description: In order to blind the study, drugs were prepared as coded tablets. The second researcher distributed the supplements without knowing the code of the tablets (60 tablets to each group for consumption in a period of 2 months) and the participants were unaware of the type of tablets consumed during the study. Also, data analysis was done blindly. 3 Dysmenorrhea. Intervention 1: Control group: Research units in the control group will receive one placebo capsule containing lactose and microcrystalline cellulose daily for two months without the active ingredient in terms of calcium and vitamin B1. The capsules in the three groups were identical in color, shape, and size and were produced by the Industrial Pharmaceutical Laboratories of the Faculty of Pharmacy, Mashhad University of Medical Sciences. Intervention 2: Intervention Group 1: Research units in this group will receive one capsule containing 100 mg of thiamine hydrochloride, lactose, and microcrystalline cellulose daily for two months. Intervention 3: Intervention Group 2: Research units in this group will receive one capsule containing 600 mg of calcium carbonate, lactose, and microcrystalline cellulose daily for two months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period starts 6 months after results are published. To whom: Researchers working in academic and scientific institutions Conditions: The data will be de-identified and usable for the purpose of developing knowledge. Where to obtain: Documents can be received via email at Kabirianm1@gmail.com and Maryam Kabirian will be responsible. How to obtain: The request will be sent via email and will be available after a period of 1 week for coordination with other members of the research team and preparation of documentation. Comments:
public Maryam Kabirian
Valiasr St., Mehr Blvd., Torbat Heydariyeh University of Medical Sciences Campus
Torbat Heydariyeh Iran (Islamic Republic of) 9516160061 +98 51 5242 1000 Kabirianm1@gmail.com Torbate-Heidaria University of Medical Sciences scientific Maryam Kabirian
University Campus, Mehr boulevard, Valiasr street
Torbat Heydariyeh Iran (Islamic Republic of) 9516160061 +98 51 5242 1000 Kabirianm1@gmail.com Torbate-Heidaria University of Medical Sciences Iran (Islamic Republic of) Being Iranian Being single Being at most 28 years old Having symptoms of menstrual distress for at least 3 cycles in the last 6 months Having mild to moderate dysmenorrhea by Visual Analog Scale (2≤VAS ≤8) Having regular menstrual cycle Having a normal body mass index . 18 years 26 years Female Having symptoms of secondary dysmenorrhea Having a history of any chronic medical disease Use psychoactive drugs Having experience of using oral contraceptive pills in the previous 6 months Following a special diet Using of tobacco or alcoholic beverages Being a professional athlete N94.6 Dysmenorrhea, unspecified Placebo Treatment - Drugs Treatment - Drugs Control group: Research units in the control group will receive one placebo capsule containing lactose and microcrystalline cellulose daily for two months without the active ingredient in terms of calcium and vitamin B1. The capsules in the three groups were identical in color, shape, and size and were produced by the Industrial Pharmaceutical Laboratories of the Faculty of Pharmacy, Mashhad University of Medical Sciences. Intervention Group 1: Research units in this group will receive one capsule containing 100 mg of thiamine hydrochloride, lactose, and microcrystalline cellulose daily for two months. Intervention Group 2: Research units in this group will receive one capsule containing 600 mg of calcium carbonate, lactose, and microcrystalline cellulose daily for two months. Severity of pain. Timepoint: One cycle before the intervention and one cycle after the intervention. Method of measurement: Visual Analog Scale. Menstrual distress. Timepoint: One cycle before the intervention and one cycle after the intervention. Method of measurement: Moos Menstrual Distress Questionnaire. Torbate-Heidaria University of Medical Sciences Approved 2018-02-20 Ethics committee of Torbat Heydariyeh University of Medical Sciences University Campus, Mehr boulevard, Valiasr street Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)