The effect of oral vitamin D on depression, anxiety and general health in menopausal women.

Determining the effect of vitamin D on anxiety, depression and general health in menopausal women.

This is a randomized clinical trial, double-blind study with a control group and design for parallel groups. To randomization, Randomizer statistical program will be used.

Sampling will be continuously done among menopausal women who referring to the gynaecology clinic of Shahid Akbarabadi Hospital. Initially, after 15 to 20 minutes of rest in a quiet environment, each participant will complete the personal information Questionnaire, Beck Anxiety and Depression scales, General Health Questionnaire (GHQ) and Menopause Rating Scale (MRS). After completing the questionnaires, 10 ccs of venous blood will be collected to measure vitamin D, parathyroid hormone, calcium, phosphorus, AST, ALT, albumin, and creatinine. The drug registration sheet will be provided to the participants for recording regular and weekly use of vitamin D and placebo. During eight weeks of intervention, the experimental group participants will weekly receive one dose of 50,000 units vitamin D, and the control group a placebo as well. Research samples and researchers will not know the content of the package until the end of data analysis. At the end of week eight of the intervention, participants will be asked to refer to the gynaecology clinic to complete the Beck Anxiety and Depression scales, GHQ, and MRS. At this time, re-blood sampling will be done for measuring serum vitamin D, parathyroid hormone, calcium, phosphorus, AST, ALT, albumin, and creatinine.

Inclusion criteria: Menopausal women with 45 to 65 years old. Conditions of non-entry: Vitamin D level greater than 30 nmol/L.

Vitamin D group, placebo group.

Anxiety, depression, general health.

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.

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.