Study of the effect of vitamin D3 on improvement of bacterial vaginosis
Phase 3
Recruiting
- Conditions
- Bacterial vaginosis.Acute vaginitisN76.0
- Registration Number
- IRCT20150609022637N7
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Premenopausal women aged> 16 years
Serum 25 (OH) D concentration of < 20 ng / ml
Having bacterial vaginosis
Exclusion Criteria
Concurrent vaginal candidiasis or trichomoniasis
Being in the bleeding phase of menstruation
Systemic or vaginal use of antibiotics in the past 2 weeks
Pregnancy
Lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients respond clinically defined as those with normal vaginal discharge, vaginal secretion pH < 4.5, and negative whiff test. Timepoint: At baseline and 14 days after completion of treatment. Method of measurement: Self reported characteristics of vaginal discharge including odor and color of discharge, measurement of pH of vaginal secretion with pH strips, for performing the whiff test, several drops of 10% potassium hydroxide is added to the sample of vaginal discharge. Release of a fish amine odor indicates a positive whiff test.
- Secondary Outcome Measures
Name Time Method Percentage of clue cells on microscopic examination of the vaginal wet mount. Timepoint: At baseline and 14 days after completion of the study. Method of measurement: Microscopic examination of vaginal discharge.;Serum concentration of 25 (OH) vitamin D. Timepoint: At baseline and end of the study. Method of measurement: Laboratory tests in hospital laboratory.