Condition 1: Diabetes mellitus. Condition 2: Hypertension. Condition 3: Obesity. Non-insulin-dependent diabetes mellitus Essential (primary) hypertension Obesity due to excess calories
Conditions
Interventions
Intervention 1: Duration of intervention is 3 months in this study. At the beginning of the study 300000 International Units (IU) of Vitamin D in divided doses of six 50000 IU pearls provided by Zahra
Treatment - Drugs
Placebo
Duration of intervention is 3 months in this study. At the beginning of the study 300000 International Units (IU) of Vitamin D in divided doses of six 50000 IU pearls provided by Zahravi Pharmaceutica
In control group 6 pearls of placebo containing edible paraffin provided by Zahravi Pharmaceutical Company is consumed daily in the first week of intervention.
Sponsors
Vice Chancellor for research, Yazd University of Medical Sciences and Health Services
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Having metabolic syndrome according to the definition of National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III): • according to the definition of NCEP ATP III having at least 3 of the following conditions: 1. Abdominal obesity (waist circumference = 102 centimeters in men and = 88 centimeters in women) 2. High blood pressure (systolic blood pressure = 130 mmHg and/or diastolic blood pressure = 85 mmHg) 3. Low HDL Cholesterol levels (HDL-C < 40 mg/dl in men and <50 mg/dl in women ) 4. High levels of Triglycerides ( =150 mg/dl) 5. Fasting blood sugar = 100 mg/dl or diabetes (In this study subjects having 3 factors of high blood pressure, high blood sugar and abdominal obesity among factors of metabolic syndrome diagnosis are selected.) 2. Being in the age range of 30 to 65 years. 3. Patients with high blood pressure with no change in anti-hypertensive treatment in the last 3 months (and no change during the study) are included in the study. 4. Patients with diabetes which consume glucose lowering drugs and their drug has not changed in the last 6 weeks (and will not change during the study) are included. 5. Consent to enter the study Exclusion criteria: 1. Acute heart disease 2. Hepatic and/or renal disease 3. Hypo and hyperparathyroidism 4. Hypo and hyperthyroidism 5. Hypercalcemia with any reason 6. Pregnancy and lactation 7. Consumption of drugs which interfere with vitamin D metabolism such as anti-seizure medication. 8. Consumption of 25OHD3 supplements more than 1000 International Units (IU) per day or any kind of calcitriol. 9. losing subject's information
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist Circumference. Timepoint: Before intervention and 3 months after intervention. Method of measurement: By tape ,with the accuracy of 0.5 Centimeters.;Hip circumference. Timepoint: Before intervention and 3 months after intervention. Method of measurement: By tape in Centimeters.;Fasting blood sugar. Timepoint: Before intervention and 3 months after intervention. Method of measurement: With Enzymatic colorimetry method in mg/dl.;Blood pressure. Timepoint: Before intervention and 3 months after intervention. Method of measurement: By GAMMA Sphygmomanometer in mmHg.;Fasting blood insulin. Timepoint: Before intervention and 3 months after intervention. Method of measurement: With Chemiluminescence method in mg/dl.;Glycated hemoglobin HbA1c. Timepoint: Before intervention and 3 months after intervention. Method of measurement: With Turbidometry method in mg/dl.;25OHD3. Timepoint: Before intervention and 3 months after intervention. Method of measurement: With Chemiluminescence method in nmol/L. | — |
Secondary
| Measure | Time frame |
|---|---|
| Age. Timepoint: Before intervention. Method of measurement: By asking, in Years.;Education. Timepoint: Before intervention. Method of measurement: Years of successful education, by asking.;Occupation. Timepoint: Before intervention. Method of measurement: Occupation that subject provides a livelihood through, by asking.;Weight. Timepoint: Before intervention and 3 months after intervention. Method of measurement: By seca scale and accuracy of 0.1 kilogrames.;Height. Timepoint: Before intervention. Method of measurement: By seca non elastic tape, in centimeters. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Azade Najjarzade
Nutrition Department, Health Faculty, Shahid Sadoughi University of Medical Science and Health Servi
Outcome results
None listed