this study is a double-blind,clinical trial prospective study,based on National Institute Of Health(1990) criteria that involve:
1-CHronic Anovulation
2-clinical or biochemical evidence of hyper Androgenism and
3-role out of other causes
women with Poly Cystic Ovary Syndrome in range of 15-40 years of age determine that their Calcum(8.7-10.2mg/dl) and Creatinin(0.5-0.9mg/dl) serum are normal and Viamin D3 serum is lower than normal{30ngr/ml}(is determine with check of blood sampling)
they enroll in study and devide in 4 groups of 20 patients base on a random number table,and for 4 months treat and follow up the following:
1-group 1 :treat with Metformin{1500mg/day}.
2-group 2 treat with Metformin{with dose above}plus Calcium{1000mg/day} and Pearl vitamin D3{ 50000IU/ every two weeks}.
3-group 3 treat with Calcium and pearl vitamin D3{with doses above} and
4-group 4: recieve Placebo{low calory sweetener tablets}
with writing of menstural days by patients(interval between regular menses is 24-35 days) and
forasmuch ovulation is criteria for regular mense and ovulation is determine with dominant folicle{equal or upper than 14mm};so in these patients do sonography of uterus and adenex in first and the end of period to evaluate dominant folicle. exclude criteria are:
1-Cushing syndrome
2-Renal Failure(Creatinin equal or upper than 1.5mg/dl)
3-Ovary and Adrenal Tumor that secreted Androgen
4-primary and secondary hyper Parathyroidism
5-Osteomalasia
6-Cancers
7-Gasterectomy
8-Mental Retardation
9-Anti Convuisive Drugs
10-Congenital Adrenal Hyperplasia and
secondary exclude criteria are Diarrhea.Vomiting and severe abdominal Distention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308037513N3
Registration date:2013-10-03, 1392/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-03, 1392/07/11
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Calcium and Vit D supplemention effects on menstrual cycle in Poly Cystic Ovary Syndrome women with National Institute Of Health criteria
Public title
Calcium and Vitamin D supplemention effects on menstrual cycle in Poly Systic Ovary Syndrome women
Purpose
Treatment
Inclusion/Exclusion criteria
include criteria:women in the range of 15-40 years of the age with Poly Cystic Ovary Syndrome that their Calcum(8.7-10.2mg/dl) and Creatinin(0.5-0.9mg/dl) serum are in normal range and they have vitamin D3 serum lower than normal{30ngr/ml}.
exclude criteria:
Cushing Syndrome؛Renal Failur(Creatinin equal or upper than 1.5mg/dl)
Ovary and Adrenal Tumor that secreted Androgen؛Primary and Secondary hyper Parathyroidism؛Osteomalasia؛Cancers؛Gasterectomy؛Mental Retardation؛Anti Convuisive Drugs؛Congenital Adrenal Hyperplasia and
secondary exclude criteria are Diarrhea؛Vomiting؛severe abdominal Distention.