Comparison of the effects of calcium and vitamin B1 on the severity of menstrual distress in 18-26 year old girls residing in dormitories

To compare of the effect of calcium and vitamin B1 on the severity of menstrual distress

A clinical trial with a control group and 2 experimental groups, with parallel groups, triple-blind, randomized, phase 3 on 123 patients, where Excel software was used for randomization.

In this triple-blind study, students living in dormitories of Torbat Heydariyeh University of Medical Sciences, in Iran assigned to 3 groups. Each person participated in the study for 4 cycles. The first cycle was to record the severity of menstrual pain and distress, 2 cycles of taking the drug or placebo, and the last cycle was to record the outcome.

Inclusion criteria: 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). Exclusion criteria: 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.

Intervention Group 1: Vitamin B1 Consumers: In this group, the research units will use a capsule containing 100 mg of thiamine hydrochloride, lactose, and microcrystalline cellulose daily for two months. Intervention Group 2: Calcium Consumers: In this group, the research units will use a capsule containing 600 mg of calcium carbonate daily for two months, as well as some lactose and microcrystalline cellulose as excipients. Control Group: In this group, the research units will use a placebo capsule containing some lactose and microcrystalline cellulose daily for two months.

Pain score, menstrual distress severity score, side effects

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.

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.

All data is potentially shareable after de-identifying individuals.

Access period starts 6 months after results are published.

Researchers working in academic and scientific institutions

The data will be de-identified and usable for the purpose of developing knowledge.

Documents can be received via email at Kabirianm1@gmail.com and Maryam Kabirian will be responsible.

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.