The Effect of Vitamin D on the Treatment of Anogenital Warts Related Human Papillomavirus (HPV)

Phase 3

Recruiting

Conditions: Anogenital warts related human papillomavirus.
Anogenital (venereal) warts
A63.0

Registration Number: IRCT20230827059276N1

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Having one or more anogenital wart(s)
20-70 years old

Exclusion Criteria

Treatment of warts by any method in the last month
History of vitamin D allergy
Users of vitamin D supplements
Pregnancy
Breastfeeding
People suffering from other skin diseases
Patients with immunosuppressive disorders, including diabetes, AIDS, and splenectomy
Users of immunosuppressive medications including steroids, cytostatics and interferon, prednisone, orlistat, phenytoin, and thiazide diuretics may alter vitamin D levels.
Users of drugs such as phenobarbital, carbamazepine, dexamethasone, nifedipine, spironolactone, clotrimazole, rifampin, which reduce vitamin D levels by producing hepatic cytochrome p450.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment response of the anogenital warts. Timepoint: The checklist related to the state of AGWs (size, location, and number) will be evaluated and completed before initiating the intervention, and the fourth and eighth weeks after the intervention. Method of measurement: The checklist related to the state of AGWs (size, location, and number); The response to treatment is considered according to the percentage of reduction in number of warts as follows: excellent (75-100% reduction of total wart count), very good (74-50% reduction), good (49-25% reduction), and poor (<25% reduction or no response).

Secondary Outcome Measures

Name	Time	Method
The recurrence of anogenital warts during a 3-month follow-up period. Timepoint: After the completion of the treatment period, it will be recorded in the related checklist monthly for three months. Method of measurement: Checklist.;Human papillomavirus related quality of life (HPV-QoL) score. Timepoint: The HPV-QoL score will be measured once before the intervention, at the end of the intervention, and monthly during the 3-month follow-up period. Method of measurement: HPV-QoL questionnaire including 15 items.;Adverse events. Timepoint: Adverse events will be asked monthly on a specific day from the participants. Method of measurement: The adverse events will be asked of the participants by telephone and will be recorded in the relevant checklist.