Effect of Vitamin D on Sexual Function and Depression of Wome

Phase 3

Recruiting

Conditions: Condition 1: Sexual dysfunction. Condition 2: Depression.
Sexual dysfunction not due to a substance or known physiological condition
Other depressive episodes

Registration Number: IRCT20100414003706N33

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 72

Inclusion Criteria

Married women aged 18-40 years
Educational level at minimum 6 years and ability to complete study questionnaires
The serum level of 25-hydroxy vitamin D less than 20 ng/ml in the vitamin D deficiency group and 20-30 ng/ml in the vitamin D insufficiency group
Impaired sexual function (a score of 28 or less based in the FSFI)
Living with her husband in the last month and following three months

Exclusion Criteria

Unwillingness to participate in the study
Pregnancy
The first six months after delivery
Severe depression based on Beck Depression Inventory
Consumption of more than 50 000 IU vitamin D supplements during the past 3 months
Drug and alcohol addiction of each of the couples
Occurrence of any stressful event or important psychological problem in the last 6 months, according to participant report
Taking any drug affecting serum levels of vitamin D (e.g. glucocorticoids, glycosides, thiazide diuretics, phenobarbital, phenytoin, cholestyramine, and calcium-vitamin D supplements)
History of chronic diseases such as thyroid and pituitary diseases, according to participant report
History of any cancer
History of infertility
Taking antidepressants or antipsychotics in the past 6 months
Genital surgery
Vaginal infection, according to participant report
Premature menopause
Husband major sexual function problems, according to woman report

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual function score. Timepoint: At the baseline (before intervention) and just after completion of the intervention (3 months after initiation of the intervention ). Method of measurement: Using the FSFI questionnaire.;Depression score. Timepoint: At the baseline (before intervention) and just after completion of the intervention (3 months after initiation of the intervention ). Method of measurement: Using the Beck Depression Inventory questionnaire.

Secondary Outcome Measures

Name	Time	Method
Side events. Timepoint: during 12 weeks after initiation of intervention. Method of measurement: self- report.;Level of serum vitamin D. Timepoint: At the baseline (before intervention) and just after completion of the intervention (3 months after initiation of intervention ). Method of measurement: Measurement of serum vitamin D levels by kits using enzyme immunoassay.;Satisfaction from the intervention. Timepoint: At the end of the intervention. Method of measurement: Using 10 cm visual analogue scale.