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IRCT20090901002394N47 IRCT 2023-06-27 Iran University of Medical Sciences The combined effect of vitamin D and zinc on premenstrual syndrome 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 2023-07-01 anticipated 96 Complete https://irct.ir/trial/70347 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Premenstrual Syndrome (PMS). Intervention 1: intervention group : In this group, 48 people with premenstrual syndrome take a vitamin D supplement of 2000 units and a zinc supplement in the form of zinc gluconate tablets containing 30 mg of elemental zinc every day for up to 8 weeks. These supplements are made by jalinous company. Intervention 2: Control group: In this group, there are 48 people receiving placebo who take capsules completely similar to the original supplements for 8 weeks.The manufactured placebo for vitamin D includes edible paraffin, which is completely similar to vitamin D3 in terms of appearance, color, smell, size, and packaging, and also the placebo for zinc supplementation contains starch. Placebos are made by Galenus company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Participants privacy
public Zahra Esmailpour
Ibn Sina Student Dormitory, Behdad Shayeg, South Amir Kabir St., end of Jalal El Ahmad Highway, Tehran
Tehran Iran (Islamic Republic of) 1461614745 +98 21 5526 1111 esmailpour.zahraa@gmail.com Iran University of Medical Sciences scientific Zahra Esmailpour
Ibn Sina Student Dormitory, Behdad Shayeg, South Amir Kabir St., end of Jalal El Ahmad Highway, Tehran
Tehran Iran (Islamic Republic of) 1461614745 +98 21 5526 1111 esmailpour.zahraa@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Single women with a regular menstrual cycle between 24 and 35 days The suitable age for the study is 18-30 years old BMI of the studied women is between 18.5 and 24.9 Not taking any contraceptive pills Not taking anti-inflammatory, anti-depressant and psychotic drugs Not doing sports professionally Not taking vitamin D and zinc supplements for 3 months before starting the study Willingness, satisfaction and ability to carry out and complete the study and cooperate with the research 18 years 30 years Female Being married Having vitamin D deficiency Suffering from an endocrine disorder such as thyroid failure, polycystic ovary syndrome and diabetes mellitus History of gynecological disorders History of autoimmune diseases Suffering from chronic and acute diseases (acute or chronic kidney failure, acute or chronic liver failure, chronic inflammatory disease or any known malignancy) Having irregular menstrual cycles (Less than 24 days and more than 35) Having stress caused by the death of relatives, surgery or marriage in the previous three months History of psychiatric diseases N94.3 Premenstrual tension syndrome Treatment - Other Placebo intervention group : In this group, 48 people with premenstrual syndrome take a vitamin D supplement of 2000 units and a zinc supplement in the form of zinc gluconate tablets containing 30 mg of elemental zinc every day for up to 8 weeks. These supplements are made by jalinous company. Control group: In this group, there are 48 people receiving placebo who take capsules completely similar to the original supplements for 8 weeks.The manufactured placebo for vitamin D includes edible paraffin, which is completely similar to vitamin D3 in terms of appearance, color, smell, size, and packaging, and also the placebo for zinc supplementation contains starch. Placebos are made by Galenus company Depression score in Beck's Depression Inventory. Timepoint: At baseline and after8 weeks. Method of measurement: Beck's Depression Inventory. Depression score in Beck Anxiety Inventory. Timepoint: At baseline and after8 weeks. Method of measurement: Beck Anxiety Inventory. The score of The premenstural symptoms screening tool (PSST). Timepoint: At baseline and after8 weeks. Method of measurement: The premenstural symptoms screening tool (PSST). The levels of total antioxidant capacity. Timepoint: At baseline and after8 weeks. Method of measurement: ELISA Kit. Weight. Timepoint: At baseline and after8 weeks. Method of measurement: Scale. Body mass index. Timepoint: At baseline and after8 weeks. Method of measurement: Calculation. Waist circumference. Timepoint: At baseline and after8 weeks. Method of measurement: Measuring tape. Iran University of Medical Sciences Approved 2023-05-24 Ethics committee of Iran university of medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)