Objective: Effect of omega3 supplementation on oxidated low density lipoprotein ,interleukin6 and hsCRP in women with polycystic ovary syndrome.
Sixty four women with PCOS(20-40 years) with a BMI >25 inclusion criteria/filling the consent form divide in to 2groups randomly. Capsules of fish-oil (3 g/d) and placebos for 2 month. Type of the study is Randomized Double Blind Placebo-controlled Clinical Trial. Blood samples oxidated low density lipoprotein, interleukin6 and hsCRP and androgens are measured in both groups before and after intervention
General information
Acronym
PCOS,oxLDL,SHBG,hsCRP
IRCT registration information
IRCT registration number:IRCT201112318564N1
Registration date:2012-08-11, 1391/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-11, 1391/05/21
Registrant information
Name
Niloofar Vaziri
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1836 7633
Email address
niloofar_vzr@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute for Reproductive Sciences, Research and Cinical Center for Infertility
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega3 supplementation on oxidated low density lipoprotein ,interleukin6 and hsCRP in women with polycystic ovary syndrome
Public title
Effect of omega3 supplementation in women with polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: females 20-40 years; PCOS diagnostic according to Roterdam criteria and BMI>25; no history about intake of any drug during the last 3 months that may affect the insulin sensitivity or hormonal profile such as: oral contraceptives, glucocorticoids, ovulation induction agents, anti diabetic and anti obesity drugs, estrogenic, antiandrogenic or anti hypertensive medication; not being in any diet in the last 3month; do not have any addiction to tobacco and alcohol; do not taking a Omega-3 supplement in the last 3 months; do not be menopaused; do not use anti-coagulant medicine; do not use anti-depression medication and do not be diabetic and hypothyroidism.
Exclusion criteria: essentially needs for intake of OCP to treatment; do not will to be in the study; do not obey the protocols of the study and do not digest more than 20% of supplements.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Institute for Reproductive Sciences, Research and clinical Center for InfertilityShahid sadoughi uni
Street address
yazd-Safaeeye-Bouali avenue, Institute for Reproductive Sciences, Research and clinical Center for Infertility