Effect of vitamin D supplementation on anxiety and inflammation in diabetic women.
Phase 2
- Conditions
- type 2 diabetes mellitus.Non-insulin-dependent diabetes mellitus
- Registration Number
- IRCT20170927036451N1
- Lead Sponsor
- Vice chancellor for research,Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Tendency to cooperate with research project
Fasting blood higher than 126 milligram per deciliter or a two-hour blood sugar higher than 200 milligram per deciliter
Age: 20 to 50 years; serum 25 Hydroxy vitamin D level less than 30 nanogram per milliliter
Detection of mild or severe anxiety by the DASS21 questionnaire
Exclusion Criteria
Have not past medical history of attack or stroke; Severe depression in the previous years
Taking Orlistat drugs (Venostat, Zenical) and anti-epileptic drugs such as phenobarbital and phenytoin
Taking any supplements such as multivitamin and vitamin d during the 4 months prior to the study
Smoking , alcohol intake
pregnancy or lactation
Not wanting to continued cooperation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaspin hormone serum levels. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Blood testing (by ELISA kit).;Omentin hormone serum levels. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Blood testing (by ELISA kit).;Interleukin-10 serum levels. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Blood testing (by ELISA kit).;CRP serum levels. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Blood testing (by ELISA kit).;Anxiety score. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: by DASS21 questionnaire.;Depression score. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: by DASS21 questionnaire.;Stress score. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: by DASS21 questionnaire.
- Secondary Outcome Measures
Name Time Method BMI. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: computing.;Waist circumference. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Strip meter.;Weight. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Scales.;Vitamin D serum levels. Timepoint: Before and 16 weeks after the start of intervention. Method of measurement: Blood testing (by ELISA kit).