Protocol summary

Summary
Objective: To evaluate and compare the efficacy of supplemental magnesium, vitamin D, vitamin C, zinc and calcium on cardiovascular and metabolic factors in infertile women with polycystic ovary syndrome. Design: Randomized, double-blind, without placebo, single center. Sample volume: Five groups of 40-patient-sized. Inclusion criteria: Abnormal menstrual cycles, polycystic ovaries in sonography, chemical or clinical signs of hyper androgenism. Exclusion criteria: History of any underlying and chronic disease, history of pelvic or abdominal surgery, partner's infertility, abnormal level of serum prolactine, smoking, current or previous using of statins in last 2 months, insuline usage, corticosteroid usage, history of neoplastic disease. Systolic and diastolic blood pressure, blood glucose, insulin, total cholesterol, HDL, LDL, testosterone, DHEA sulfate levels sterilized Andrew supplement intake. Interventions: Patients were randomly divided into five groups and thus the treatment is assigned to them: Control group: Will receive only Metformin 100 mg daily Intervention groups: 1- One thousand milligrams of calcium and 400 IU vitamin D twice a day with metformin 100 mg daily 2 - Zinc sulfate capsules daily with metformin 100 mg daily 3 - Tablets of magnesium 250 milligrams daily with metformin 100 mg daily 4 - Vitamin C, two thousand milligrams daily with metformin 100 mg daily Than the patients at baseline and at the end of the treatment, after bearing eight to twelve hours overnight fasting, will be tested for these parameters: Systolic and diastolic blood pressure, blood glucose, insulin, total cholesterol, HDL, LDL, testosterone, DHEA sulfate and serume level of intake supplements. The main outcome of these patients is to improve cardiovascular and metabolic factors.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013110615307N1
Registration date: 2014-04-05, 1393/01/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-05, 1393/01/16
Registrant information
Name
Roghaieh Anvari Ali Abad
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
ranvari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study effect of supplements (magnesium, vitamin D, vitamin C, zinc and calcium) on cardiometabolic factors in infertile women with polycystic ovary syndrome.
Public title
Effect of magnesium, vitamin D, vitamin C, zinc and calcium Supplements on cardiometabolic parameters in infertile women with polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Abnormal menstrual cycles, polycystic ovaries in sonography, chemical or clinical signs of hyper androgenism. Exclusion criteria: History of any underlying and chronic disease, history of pelvic or abdominal surgery, partner's infertility, abnormal level of serum prolactin, smoking, current or previous using of statins in last 2 months, insuline usage, corticosteroid usage, history of neoplastic disease.
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmide st, Pajoohesh sq
City
Hamedan
Postal code
3519638686
Approval date
2013-07-04, 1392/04/13
Ethics committee reference number
16/65/9/1049/پ

Health conditions studied

1

Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Heart condition
Timepoint
2 months after intervention
Method of measurement
Echocardiography

Secondary outcomes

1

Description
Serum lipids level
Timepoint
tow months after intervention
Method of measurement
Patients blood sampel

2

Description
Serum insullin level
Timepoint
tow months after intervention
Method of measurement
Patients blood samples patients

Intervention groups

1

Description
Intervention group: Calcium, 1000 mg orally tablets ,twice a day for 2 months, intervention group
Category
Treatment - Drugs

2

Description
Intervention group:Vitamin D, 400 mg orally Tablets, twice a day for 2 months
Category
Treatment - Drugs

3

Description
Intervention group:Zinc, 50 mg orally tablets , once daily for 2 months
Category
Treatment - Drugs

4

Description
Intervention group: Magnesium, 75 mmol oral tablet, once a day for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Marzieh Farimani
Street address
Fatemieh Hospital, Pasdaran avenue
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan Univesity of Medical Sciences
Full name of responsible person
Heydar Tavillani
Street address
Mahdiye Blvd, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan Univesity 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
Hamadan University of Medical Sciences
Full name of responsible person
Roghaieh Anvari
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh hospital, pasdaran avenue, Hamadan
City
Hamadan
Postal code
3519638686
Phone
+98 81 1252 0183
Fax
+98 81 1827 7012
Email
R.anvari@umsha.ac.ir
Web page address
www.umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Marzieh Farimani
Position
Obstetric and Gynecology Surgeon
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran avenue
City
Hamadan
Postal code
3519638686
Phone
+98 81 1827 7012
Fax
+98 81 1827 7012
Email
M.Farimanie@umsha.ac.ir
Web page address
www.umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Medicine of Scinces
Full name of responsible person
Roghaieh Anvari
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, pasdaran avenue
City
Hamedan
Postal code
3519638686
Phone
+98 81 1827 7013
Fax
+98 81 1827 7012
Email
R.Anvari@umsha.ac.ir
Web page address
www.umsha.ac.ir

Sharing plan

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