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

Protocol summary

Summary
Aims: Determining the effect of vitamin D supplementation in the treatment of uterine leiomyoma. Study design: randomized, double-blind, placebo controlled, single center, clinical trial, phase 2-3. Study population: women with uterine leiomyoma if have vitamin D deficiency will be selected as target population. Main inclusion criteria: age between 20 and 45 years, patients with uterine fibroid, which the largest is greater than 3 cm on ultrasound, vitamin D levels less than 75 nmol per liter or 30 ng per milliliter. Main exclusion criteria: myoma with acute symptoms which will require to surgery, liver or kidney disorders, of the uterus, cervix and ovarian cancers, adnexal mass, endometrial lesions, use of hormonal therapy in the last three months, pregnancy and breastfeeding, delivery within the last six months, uterine leiomyoma more than 12 cm, the size of the uterine leiomyoma more than 20 weeks, malabsorption syndrome. Sample Size: 40 patients, 20 as the intervention group and 20 in the control group (B) Interventions: The patients in case group will receive vitamin D (brand name: Vitamin-D 50000IU, manufactured by Zahravi pharmaceutical company, Iran) one pearl per week for eight weeks, after which if the levels of vitamin D was normal, vitamin D continued one pearl per month and if the levels of vitamin D was low vitamin D continued one pearl per week for 4 weeks. Patients in control group will receive placebo (manufactured by Zahravi pharmaceutical company, Iran) in similar route to intervention group. (C) The intervention time: After the evaluation and also 2, 3 and 4 months after the initiation of intervention in any visit the signs bleeding and spotting, pictorial bleeding assessment chart (PBAC) and visual analog scale (VAS) score will be evaluated. Ultrasound will be done in forth month after intervention. (D) The primary outcome: reducing the size of leiomyoma, decreasing of blood loss in patients with leiomyoma, reduce clinical signs criteria caused by Leiomyoma.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121511019N4
Registration date: 2015-02-24, 1393/12/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-24, 1393/12/05
Registrant information
Name
Mojgan Rahmanian
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1022
Email address
rahmanian@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Assessment of Vitamin D effect in compare to placebo in decreasing of leiomyoma size in patients with uterine leiomyoma
Public title
Vitamin D or placebo in treatment of uterine leiomyoma
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Study designed as double-blind clinical trial, so that the investigator and the patient do not know about what they received (drug or placebo). Be the first person in the intervention or the control group specified by tossing up and the rest assigned as every other.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard, Semnan University of medical Sciences
City
Semnan
Postal code
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
2285/2/12/93

Health conditions studied

1

Description of health condition studied
Volume and duration of mensturation, Leiomyoma of uterus, size
ICD-10 code
N92.0, N92
ICD-10 code description
Irregular menstruation, Leiomyoma of uterus, unspecified, Excessive and frequent mensturation with regular or irregular cycle

Primary outcomes

1

Description
Size of Uterine Liomyoma
Timepoint
4 months after intervention
Method of measurement
Sonography study

Secondary outcomes

1

Description
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)

Intervention groups

1

Description
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 vitamin D was normal, vitamin D continued one pearl per month and if the levels of vitamin D was low vitamin D continued one pearl per week for 4 weeks.
Category
Treatment - Drugs

2

Description
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 interventions.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Dr. Mahboobeh Saghafi
Street address
Imam Hussein Square
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mahboobeh Saghafi
Position
Gynecology resident
Other areas of specialty/work
Street address
Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 3344 0066
Fax
Email
saghafimah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mojgan Rahmanian
Position
Gynecologist/ Assistant professor
Other areas of specialty/work
Street address
Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 3346 0066
Fax
Email
Rahmanian_74@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Nurse/ Research expert
Other areas of specialty/work
Street address
Kowsar Hospital, Al Ghadir Square, Amin Ave.
City
Semnan
Postal code
Phone
+98 23 3343 7838
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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