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Study of the effect of vitamin D3 on improvement of bacterial vaginosis

Study of the effect of high dose vitamin D3 on improvement of bacterial vaginosis in vitamin D deficient women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150609022637N7
Enrollment
40
Registered
2020-06-20
Start date
2020-04-28
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis. Acute vaginitis

Interventions

Intervention 1: Intervention group: Patients will receive metronidazole tablet 500 mg twice daily for one week. Moreover, patients will receive a 50000 IU soft gel capsule of vitamin D per day for 5 d

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Premenopausal women aged> 16 years Serum 25 (OH) D concentration of < 20 ng / ml Having bacterial vaginosis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Number 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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaemeh Nikvarz

Kerman University of Medical Sciences

nnikvarz@kmu.ac.ir+98 34 3132 5017

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026