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IRCT20090810002324N18 IRCT 2021-01-02 Iran University of Medical Sciences The effect of vitamin D on depression, anxiety and general health. The effect of oral vitamin D on depression, anxiety and general health in menopausal women. 2021-01-10 anticipated 90 Complete https://irct.ir/trial/51379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, the numbers one to one hundred twenty will be randomly divided into two groups of sixty by the Randomizer statistical program. The first and second sixty numbers will be specified by the Dana pharmaceutical company on each of the containers, containing eight soft gels oral vitamin D and eight soft gels oral placebo, respectively. Containers which marked from one to one hundred twenty will be provided to the participants in the order of entering the study. At the end of the study and before analyzing the information, all of the codes that specify the content of the containers (vitamin D or placebo) will be taken from the company, so the allocation of each participant in one of the two groups will be randomly according to the registered codes on the vitamin D and placebo containers, Blinding description: Participants, researcher, and research assistant will not know how individuals allocated to each of the two intervention and control groups. All questionnaires will be gathered by the research assistant who is unaware of the allocation. 3 Condition 1: Anxiety. Condition 2: Depression. Condition 3: General health. Intervention 1: Intervention group:The participants will take weekly 50,000 units of vitamin D for a consequence of eight weeks. Intervention 2: Control group: The participants will take weekly a placebo for a consequence of eight weeks. 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 Decisions will be made in the future.
public Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1813 Keshavarz.m@iums.ac.ir Iran University of Medical Sciences scientific Mehrzad Jafarzadeh
No. 10, Firooze Alley, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593716615 +98 21 8603 6062 jafarzadehmehrzad@gmail.com Endocrinology and Metabolism Research Institute of Iran University of Medical Sciences Iran (Islamic Republic of) Age 45 to 65 years. pass of at least one year since the last menstrual period. Body mass index less than 30 kg/m^2. Physical and mental health (according to personal reporting) 45 years 65 years Female Vitamin D level above 30 nmol/L in the first blood sample. Confirmation of chronic kidney, liver, thyroid and parathyroid diseases by laboratory tests. Use of any hormone or herbal drug during the study period. Irregular consumption or missing even one dose of vitamin D or placebo. F06.4 Anxiety disorder due to known physiological condition Prevention N/A Intervention group:The participants will take weekly 50,000 units of vitamin D for a consequence of eight weeks. Control group: The participants will take weekly a placebo for a consequence of eight weeks. Anxiety score. Timepoint: At the beginning of the study and before the initial sampling, then at the end of the study (8 weeks after taking the vitamin D or placebo). Method of measurement: Beck Anxiety Inventory. Depression score. Timepoint: At the beginning of the study and before the initial sampling, then at the end of the study (8 weeks after taking the vitamin D or placebo). Method of measurement: Beck Depression Inventory. General Health. Timepoint: At the beginning of the study and before the initial sampling, then at the end of the study (8 weeks after taking the vitamin D or placebo). Method of measurement: General Health Questionnaire (GHQ). Frequency and severity of menopausal symptoms. Timepoint: At the beginning of the study and before the initial sampling, then at the end of the study (8 weeks after taking the drug or placebo). Method of measurement: The Menopause Rating Scale (MRS). The Institute of Endocrinology and Metabolism Research and Training Center, Iran University of Medical Sciences. Approved 2020-11-22 Ethic committee of Iran University of Medical sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)