]>
IRCT20150624022896N3 IRCT 2024-02-25 Esfahan University of Medical Sciences Investigating the effect of vitamin D on sexual function of women in reproductive age with type 2 diabetes Investigating the effect of vitamin D supplementation on the sexual function of women in reproductive age with type 2 diabetes in the vitamin D group compared to the placebo group 2024-04-08 anticipated 100 Complete https://irct.ir/trial/74645 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 100 participants will randomly be divided into two groups that receive either medication (n=50) or a placebo (n=50) daily during the follow-up. Random allocation will be carried out using the permuted block randomization method with sizes of 2, 4, and 6. The random sequences will be generated by the “blockrand” package in R. The capsules (placebo/trial medication) will be allocated to participants via coded drug containers of identical appearance, Blinding description: The study is double-blind. After random grouping, the samples are divided into two control and intervention groups, the researcher and the samples do not know about this grouping, only the drug and placebo codes given to the people are recorded in their questionnaire. 3 Condition 1: Sexual Dysfunction. Condition 2: Type 2 Diabetes. Intervention 1: Intervention group: Weekly prescription of Pearl Vitamin D with a dose of 50,000 made by Tehran Daru Company for 12 weeks after lunch to increase drug absorption. Intervention 2: Control group: Weekly administration of vitamin D placebo made by Tehran Daru Company for 12 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 There is no further information.
public Fatemeh Shakouri Jobani
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7153 www.farimahshakori.75@gmail.com Esfahan University of Medical Sciences scientific Maryam Kianpour
Nursing and Midwifery Research Center- Nursing and Midwifery faculty- Isfahan University of Medical Sciences- Hezar gerib Ave - Isfahan
Isfahan Iran (Islamic Republic of) 8138946497 +98 31 3792 7620 kianpour@mail.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Married women between 18 to 49 years old Not suffering from a wide range of diseases that lead to sexual dysfunction Including: multiple sclerosis and any central nervous system disorders, mental disorders, mental retardation, vasculitis, uncontrolled hypo and hyperthyroidism, anatomical defects of the reproductive system, tumors and tumors and cancer Not taking drugs affecting sexual function Including: H2 receptor blockers, sleeping pills, cardiac and antihypertensive drugs, anticonvulsants, narcotic drugs, anticancer drugs and corticosteroids, antihistamines, opioids and alcohol and psychotropic drugs, barbiturates Gynecologic health and absence of endometriosis Absence of erectile disorders in the husband Minimum literacy level of the participants Self-reported absence of alcohol and smoking addiction by the women Awareness of place and time Satisfaction and willingness to participate in research suffering from Type 2 diabetes for at least one year Not taking vitamin D supplements at least three months before entering the study Have normal levels of serum Calcium, Phosphorus, and Albumin Body mass index (BMI) should be less than 30 Absence of malabsorption disorders Having insufficient vitamin D level (10 – 30 ng/ml) 18 years 49 years Female Being pregnant or in the the firs trimester after delivery Surgical history of oophorectomy, hysterectomy, and mastectomy Early menopause (age less than 40 years) F52 E11 Sexual dysfunction not due to a substance or known physiological condition Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Weekly prescription of Pearl Vitamin D with a dose of 50,000 made by Tehran Daru Company for 12 weeks after lunch to increase drug absorption. Control group: Weekly administration of vitamin D placebo made by Tehran Daru Company for 12 weeks Sexual function. Timepoint: Before the intervention and 13 weeks after the intervention. Method of measurement: Female Sexual Function Index Questionnaire (FSFI). Vitamin D serum level. Timepoint: Before intervention. Method of measurement: HPLC kit (high performance liquid chromatography. Depression score. Timepoint: Before intervention. Method of measurement: DASS21 questionnaire score. Esfahan University of Medical Sciences Approved 2023-12-26 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Ave., Isfahan University of Medical Sciences, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)