Assessment of vitamin D oral supplementation on insulin resistance, visceral fat and adiponectin in women with polycystic ovary syndrome and hypovitaminosis D
Object: Assessment of vitamin D oral supplementation on insulin resistance, visceral fat and Adiponectin in women with polycystic ovary syndrome and hypovitaminosis D
Design: Single-blind randomized clinical trial (in patient).
Methods: We conducted a single-blind (in patients), randomized clinical trial. Fouty_four women are selected with baseline polycystic ovary syndrome. Participants were randomly assigned to two groups: The intervention group (8 vitamin D3 capsule 50000 IU during 2 month (1 capsule in the week after lunch) and the Control group: 8 placebo capsule (Paraffinedible) during 2 month (1 capsule in the week after lunch). ELISA, HOMA-IR, HOMA-B, ECL, QUICKI methods was used for data analysis.
Inclusion criteria: Women with pcos according rotterdom criteria; Vitamin D deficiency (x≤20 ng); OCPs consumer; Age between 20 to 38. Exclude criteria: Under 20 and over 38 years old; Neoplastic disorders; hepatic, renal; cardiovascular; malabsorptive and pregnancy; Those who consume vitamin D and taking antidiabetic drugs; People who follow a special diet pattern had specific physical activity
Variables: Insulin resistant; visceral fat; adiponectin were measured and compared between two groups before and the end of intervention period. Also 24 recall and exposure to sunlight questioner during the intervention were completed.
Intervention/Control: Intervention: 8 vitamin D3 capsule 50000 IU during 2 month (1 capsule in the week after lunch ). Control: 8 placebo capsule (Paraffinedible) during 2 month (1 capsule in the week after lunch)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101030248N1
Registration date:2016-11-17, 1395/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-17, 1395/08/27
Registrant information
Name
Sakineh Nouri saeidlou
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3276 6825
Email address
nourisaeidlou_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
goverment
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of vitamin D oral supplementation on insulin resistance, visceral fat and adiponectin in women with polycystic ovary syndrome and hypovitaminosis D
Public title
Assessment of vitamin D oral supplementationon on insulin resistance, visceral fat and adiponectin in women with polycystic ovary syndrome and hypovitaminosis D
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with pcos according rotterdom criteria; Vitamin D deficiency ( x=<20 ng); OCPs consumer; Age between 20 to 38
Exclude criteria: Under 20 and over 38 years old; Neoplastic disorders; hepatic; renal; cardiovascular; malabsorptive and pregnancy; Those who consume vitamin D and taking antidiabetic drugs; People who follow a special diet pattern had specific physical activity
Age
From 20 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to avoid the possible effect of awareness of allocation to treatment or placebo groups a single blind design was used which only researcher was awareness of randomizing into two groups. According to the number's of randomized table, we put patient into two groups and they did not know any things about this.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran Phone:+98 44 3223 4897 Fax: +98 44 322 290 59