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Compare The Effect of Vitamin D3 With 2 Different Doses on Metabolic Disorders in Women With Poly-cystic Ovary Syndrome and Vitamin D Deficiency.

Protocol summary

Summary
This study is a prospective and randomized single-blind clinical trial. The aim of this study is to compare the effect of vitamin D3 with 2 different doses on metabolic disorders in women with polycystic ovary syndrome and vitamin D deficiency. Total of sample size is 124 woman with ages: 18-45 years old. The patients with malabsorption, chronic renal failure, cirrhosis, pancreatitis, nephrotic syndrome, cancer, hyperprolactinemia, cushing's syndrome, congenital adrenal hyperplasia, androgen secreting tumors and pregnant and lactating patients will be excluded. The patients are randomly divided into two groups. Patients do not know about the protocol of the study and type of drug. First group receives oral dose of 50,000 IU of vitamin D once per week for 8 weeks. Second group receives oral dose of 50,000 IU of vitamin D once per month for 2 months. In both methods, 1000 mg of calcium carbonate are given twice daily throughout the treatment period. Patients basic information such as age and BMI, serum triglyceride, LDL, HDL, total cholesterol, fasting blood sugar, fasting insulin levels, vitamin D will be recorded in both groups before treatment and after the treatment period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100824426N1
Registration date: 2015-10-22, 1394/07/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Leila Moradi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
moradi.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare The Effect of Vitamin D3 With 2 Different Doses on Metabolic Disorders in Women With Poly-cystic Ovary Syndrome and Vitamin D Deficiency.
Public title
The Effect of Vitamin D3 on Metabolic Disorders in Women With Ovarian Cysts and Vitamin D Deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Women with poly-cystic ovary syndrome; vitamin D less than 30 ng/ml . Exclusion Criteria: Chronic diseases such as malabsorption, chronic renal failure, cirrhosis, pancreatitis, nephrotic syndrome; malignancies; hyperprolactimenia; cushing's syndrome; congenital adrenal hyperplasia; androgen secreting tumors; using Drugs that affect metabolic parameters such as metformin, corticosteroids in the previous three months; using vitamin D and calcium and multivitamins in the last six months.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To randomization: Consecutive odd and even numbers are assigned to patients. oral dose of 50,000 IU of vitamin D once per week for 8 weeks and oral dose of 50,000 IU of vitamin D once per month for 2 months are administered to odd and even numbered, respectively.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
ir.ajums.REC.1394.16

Health conditions studied

1

Description of health condition studied
Vitamin D
ICD-10 code
E55.9
ICD-10 code description
Avitaminosis D

Primary outcomes

1

Description
Body mass index (BMI)
Timepoint
Before treatment and after completion of treatment in the eighth week
Method of measurement
By Using the formula: weight (kg) / the square of the height (m)

2

Description
The level of vitamin D
Timepoint
Before treatment and after completion of treatment in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

3

Description
The serum levels of triglycerides, LDL, HDL, Total cholesterol
Timepoint
Before treatment and after completion of treatment in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

4

Description
Fasting blood glucose levels
Timepoint
Before treatment and after completion of treatment in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

5

Description
Fasting insulin levels
Timepoint
Before treatment and after completion of treatment in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Group I: Prescription oral dose of 50,000 IU of vitamin D once per week for 8 weeks.
Category
Treatment - Drugs

2

Description
Group II: Prescription oral dose of 50,000 IU of vitamin D once per month for 2 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Bahman Ghaderian
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mahmod Latifi
Street address
Golestan Hospital, Farvardin st., Golestan, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Leila Moradi
Position
fellowship in endocrinology and metabolic diseases
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Lmoradi16@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Homeira Rashidi
Position
Subspecialty Endocrinology and Metabolism
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Hrashidi2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

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