The combined effect of vitamin D and Zinc on symptoms of depression, anxiety, premenstrual syndrome (PMS) and Total antioxidant capacity (TAC) in people with premenstrual syndrome (PMS): a randomized, Three-blind clinical trial

Determining the effect of vitamin D and zinc supplementation on depression and anxiety, symptoms related to premenstrual syndrome (PMS) and Total Antioxidant Capacity (TAC) in people with PMS

A clinical ، three-blind, randomized, two arm parallel group, placebo-controlled trial on96 people with PMS. Randomization is done by software available on the Internet.

This study was a randomized, Three -blind, placebo-controlled trial. 96women (18–30 years) with premenstrual syndrome diagnosed according PMS questionnaire were randomly assigned to receive either 30-mg zinc gluconate and 2000IU vitamin D (group 1; n = 48) and/or placebo (group 2; n = 48) for 8 weeks. Premenstrual syndrome symptoms, total antioxidant capacity, depression, anxiety were measured at study baseline and after 8weeks intervention. In this study The researcher, the patients and the analyzer are blinded.

Single women with a regular menstrual cycle between 24 and 35 days BMI of participating women between 18.5 and 24.9 Not doing sports professionally Not taking any contraceptive pills, not taking other drugs Not receiving vitamin D and zinc supplements 3 months before the intervention Not having any history of acute and chronic diseases and gynecological disorders and psychological diseases

The intervention group will receive a daily vitamin D supplement (2000 IU) and zinc supplement (zinc gluconate tablets containing 30 mg of elemental zinc) for 8 weeks. The control group will receive placebo tablets (completely similar capsules that contain oral paraffin In terms of appearance, color, smell, size and packaging, it is completely similar to vitamin D3, and they will use placebo tablets containing starch for zinc supplementation

Depression, Anxiety, Premenstrual Syndrome (PMS), Total antioxidant capacity (TAC)

In order to randomize the samples, first, a list of 96 items is generated by the software available on the internet into two groups of 48 items that are separated by the letters A and B, and this list is provided to the researcher, and the eligible samples are referred to groups A and B are allocated. The manufacturer of the placebo is asked to put one of the labels A or B on the drug and the other on the placebo by throwing a coin and keep this confidential until the end of the data analysis, and therefore the drugs with one of the letters A or B and placebos are indicated by another letter. According to the randomization table below, the researcher will distribute the drug and placebo according to the order of reference of the samples from packages A or B, so this study will be a three-blind study, that is; The patient, the researcher and the analyst will not be aware of the type of packages received by the samples until the end of the data analysis

The manufacturer of the placebo is asked to put one of the labels A or B on the drug and the other on the placebo by throwing a coin and keep this confidential until the end of the data analysis, and therefore the drugs with one of the letters A or B and placebos are indicated by another letter. According to the randomization table below, the researcher will distribute the drug and placebo according to the order of reference of the samples from packages A or B, so this study will be a three-blind study, that is; The patient, the researcher and the analyst will not be aware of the type of packages received by the samples until the end of the data analysis