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Vitamin D or placebo in treatment of uterine leiomyoma

Assessment of Vitamin D effect in compare to placebo in decreasing of leiomyoma size in patients with uterine leiomyoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014121511019N4
Enrollment
40
Registered
2015-02-24
Start date
2015-01-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Volume and duration of mensturation, Leiomyoma of uterus, size. Irregular menstruation, Leiomyoma of uterus, unspecified, Excessive and frequent mensturation with regular or irregular cycle

Interventions

Intervention 1: The patients in case group will receive vitamin D pearl (brand name: Vitin-D 50000IU, manufactured by Zahravi pharmaceutical company, Iran)one per week for eight weeks, after which if
Treatment - Drugs
Placebo
Patients in control group will receive placebo pearl (manufactured by Zahravi pharmaceutical company, Iran) in similar route to intervention group for 8 weeks and followed without any additional inter
The patients in case group will receive vitamin D pearl (brand name: Vitin-D 50000IU, manufactured by Zahravi pharmaceutical company, Iran)one per week for eight weeks, after which if the levels of vi

Sponsors

Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age between 20 and 45 years, having one or more uterine fibroids, the largest be 3 cm based on ultrasound, vitamin D and 25-hydroxyvitamin D concentrations lower than 75 nmol per liter or 30 ng/ml. Exclusion criteria: Leiomyoma with acute symptoms which requiring to immediate surgical intervention, liver or kidney disorders, cancer of the uterus, cervix and ovarian, adnexal mass, endometrial lesions such as polyps on ultrasound, use of hormonal therapy in the last three months, pregnancy, lactation or the desire to become pregnant during the study period, delivery within the last six months, uterine myoma in size more than 12 cm, the size of the uterine leiomyoma more than 20 weeks, history of gastrointestinal problems, especially malabsorption syndrome.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Size of Uterine Liomyoma. Timepoint: 4 months after intervention. Method of measurement: Sonography study.

Secondary

MeasureTime frame
Menstrual bleeding and related symptoms. Timepoint: 2, 3 and 4 months after intervention. Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC) and Visual analog scale (VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahboobeh Saghafi

Semnan University of Medical Sciences

saghafimah@yahoo.com+98 23 3344 0066

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 23, 2026