Effect of calcium plus vitamin D supplementation on insulin resistance in patients with poly-cystic ovary syndrome and vitamin D deficiency.
Design: single-blind clinical, randomized in available, two intervention and control groups.
Inclusion criteria: women 18 to 40 years old with polycystic ovary syndrome and a lack of vitamin D.
Exclusion criteria: patients with Cushing's syndrome; congenital adrenal hyperplasia; hyperprolactinemia; hypothyroidism; hyperthyroidism; androgen-secreting tumors; Severe vitamin D deficiency (<10 ng/ml); all the diseases that affect the level of vitamin D; such as kidney disease and liver.
The main outcome variables, interventions: 60 eligible patients referred to the clinics of Semnan University of Medical Sciences were enrolled in the study. and Demographic information and testing sessions have been collected and tested by HOMA-IR and FAI calculated randomly into two groups: 1) Intervention: treatment with vitamin D and calcium (50,000 IU weekly, supplemental vitamin D and 1000 mg daily supplement calcium orally for 8 weeks); 2) the control group. After 8 weeks, demographic information, and the tests were evaluated and the index is calculated by HOMA-IR and FAI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122625732N10
Registration date:2017-02-19, 1395/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of calcium plus vitamin D supplementation on insulin resistance in patients with poly-cystic ovary syndrome and vitamin D deficiency
Public title
Effect of calcium plus vitamin D supplementation on insulin resistance in patients with poly-cystic ovary syndrome and vitamin D deficiency
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women 18 to 40 years old with polycystic ovary syndrome and a lack of vitamin D.
Exclusion criteria: patients with Cushing's syndrome; congenital adrenal hyperplasia; hyperprolactinemia; hypothyroidism; hyperthyroidism; androgen-secreting tumors; Severe vitamin D deficiency (<10 ng/ml); all the diseases that affect the level of vitamin D; such as kidney disease and liver.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Semnan University of Medical sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
semnan
Postal code
3514799442
Approval date
2016-09-13, 1395/06/23
Ethics committee reference number
IR.SEMUMS.REC.1395.123
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
Vitamin D
Timepoint
The beginning and end of the study
Method of measurement
Experiment
2
Description
Calcium
Timepoint
The beginning and end of the study
Method of measurement
Experiment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: there is no intervention in the control group.
Category
Behavior
2
Description
Intervention Groups: to each of the patients in the intervention group, 50,000 units of vitamin D weekly and 1,000 mg daily calcium supplements orally administered for 8 weeks to patients. After 8 weeks of testing re-done.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Semnan University of Medical Sciences
Full name of responsible person
Majid Foroutan
Street address
Semnan University of Medical Sciences, Basij Blvd,Semnan.
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
Semnan University of Medical Sciences, Basij Blvd, Semnan
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
Majid Foroutan
Position
Endocrinologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@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
Majid Foroutan
Position
Endocrinologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@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
Majid Foroutan
Position
Endocrinologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)