The aim of this study is to evaluate the effect of vitamin D3 supplementation on bone biochemical factors, serum magnesium and zinc in polycystic ovarian syndrome (PCOS). 54 women with PCOS who are 18-40 years old and meet the inclusion criteria would be recruited from clinics of Tabriz University of medical sciences. The patients are assigned as a double blind manner into placebo or intervention groups based on age and whether consume drugs. The intervention group receives oral vitamin D3 supplement one tablet every 20 days for 60 days (50000 IU vitamin D3/tablet) and the placebo group receive placebo in the same way. Serum alkaline phosphatase, calcium, phosphorus, magnesium and zinc are measured at baseline and after intervention in 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201043140N3
Registration date:2012-01-13, 1390/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-13, 1390/10/23
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student research committee
Expected recruitment start date
2011-04-09, 1390/01/20
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral vitamin D3 supplementation on bone biochemical factors, serum magnesium and zinc in polycystic ovary syndrome
Public title
Effect of oral vitamin D3 supplementation on biochemical factors in polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of PCOS based on Rotterdam criteria (presence of two of the three following characteristics: 1. oligomemorreha /amenorrhea, 2. chemical or clinical finding of hyperandrogenism and 3. polycystic appearance of ovary); voluntary consent for participation in the study; female aged 18-40 years. Exclusion criteria: Other common causes of hyperandrogenemia and/or anovulation; hyperprolactinoma; congenital adrenal hyperplasia; Cushing syndrome, and virilizing ovarian or adrenal tumors; diabetes mellitus and heart, kidney and liver dysfunction; using vitamin D or Calcium supplement, metformin or insulin sensitizing drugs, corticosteroids, anticonvulsants during last 2 month or during the study; Smoking; alcohol abuse; breast feeding and pregnancy.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Research Vice-chancellor, central building, number 2, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
51665-118
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
9065
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
improvement of bone biochemical factors
Timepoint
before and after intervention (60 days)
Method of measurement
serum levels of alkaline phosphatase, calcium, phosphoruse
2
Description
improvement of serum zinc and magnesium
Timepoint
before and after intervention (60 days)
Method of measurement
serum levels of zinc and magnesium
Secondary outcomes
1
Description
food habits
Timepoint
before and after intervention (60 days)
Method of measurement
3 days 24h dietaty racall
2
Description
anthropometric indicator
Timepoint
before and after intervention (60 days)
Method of measurement
Body weight without shoes with calibrated scale, Standing height without shoes are measuredl. BMI was calculated with this equation: W(kg) /H(m)2
Intervention groups
1
Description
control group: placebo every 20 days for 60 days
Category
Placebo
2
Description
intervantion group: 50000 IU vitaminD3 every 20 days for 60 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital and Pardis clinic
Full name of responsible person
Hania Rahimi
Street address
Artesh street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student research committee
Full name of responsible person
Dr. Saeed Pirouz Panah
Street address
Health & Nutrition Faculty, Tabriz university of medical sciences, Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student research committee
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
Health and Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Hania Rahini
Position
student
Other areas of specialty/work
Street address
Health & Nutrition Faculty, Tabriz university of medical sciences, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1330 4779
Fax
Email
hania.rahimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health & Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Hania Rahimi
Position
student
Other areas of specialty/work
Street address
Health & Nutrition Faculty, Tabriz university of medical sciences, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1330 4779
Fax
Email
hania.rahimi@gamil.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Neda Seyed Sadjadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)