The effect of vitamin D supplementation on anthropometric indices and androgen hormones in women with polycystic ovary syndrome treated with low calorie diet
objective: The aim of this study is to determine the effects of vitamin D supplementation on anthropometric indices and androgen hormones in women with polycystic ovary syndrome treated with low calorie diet. Study design: Parallel double-blind(both patients and researchers) randomized controlled clinical trial. In this study 60 overweight and obese polycystic ovary syndrome women with vitamin D deficiency referred to Izady hospital in Qom city will be selected. Patients will be assigned into two groups to receive vitamin D with dosage of 50000 IU/week (n=30) or placebo (n=30). Patients in Both groups will be received low calorie diet (An average of 500 kcal). Vitamin D supplements and placebos pill are similar in shape and size. Patients were advised to continue physical activity habits without any changes during intervention. Before intervention and after 12 weeks participants will be evaluated for anthropometric indices, body composition analysis and androgenic profile.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062710826N19
Registration date:2016-12-08, 1395/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on anthropometric indices and androgen hormones in women with polycystic ovary syndrome treated with low calorie diet
Public title
effect of Supplementation in combination with diet therapy in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 18-40 years old, Patients with PCOS according to Rotterdam criteria, BMI between 25 to 40, Serum vitamin D levels less than 20 ng /ml, not using weight loss diet and vitamin D supplement Over the last 3 months, not using hormone therapy, not using certain drugs including Weight loss drugs and multivitamin supplements mineral, not smoking, not doing heavy and professional exercise. Exclusion criteria: individuals with diabetes,
Cardiovascular disease, Liver, kidney, thyroid and para- thyroid, Cushing's syndrome, osteomalacia, changes in physical activity, Non-compliance with diet and supplementation
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
Shahid Sadoughi University of Medical Sciences, alem square