Effects of vitamin D and calcium co-supplementation on inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D women with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of vitamin D and calcium co-supplementation on inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-40 years with overweight diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 104 women with PCOS eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D/week and 1000 mg calcium/d co-supplement (intervention group: n=26), 50000 IU vitamin D/week supplement (intervention group: n=26), 1000 mg/d calcium supplement (intervention group: n=26) or placebo (control group: n=26). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure inflammatory factors and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks. Outcomes: Serum hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA) will be measured at baseline and end-of-trial
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407015623N21
Registration date:2014-08-24, 1393/06/02
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-08-24, 1393/06/02
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D and calcium co-supplementation on inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Women aged 18-40 years with deficient vitamin D; diagnosed with PCOS.
Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; antidiabetic medications; anti-obesity medications.
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:
104
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak