Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome
Ключови думи
Резюме
Дати
| Последна проверка: | 10/31/2010 |
| Първо изпратено: | 11/08/2010 |
| Очаквано записване подадено: | 11/08/2010 |
| Първо публикувано: | 11/09/2010 |
| Изпратена последна актуализация: | 08/16/2011 |
| Последна актуализация публикувана: | 08/17/2011 |
| Действителна начална дата на проучването: | 09/30/2010 |
| Приблизителна дата на първично завършване: | 02/29/2012 |
| Очаквана дата на завършване на проучването: | 02/29/2012 |
Състояние или заболяване
Интервенция / лечение
Drug: Vitamin D
Behavioral: Lifestyle measures
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: Vitamin D All patients will be instructed to exercise and lose weight according to the NCEP-ATP III diet. The participants will be randomized in an open manner into one of the following 2 treatment groups: a) cholecalciferol (VitD3) (2200 IU/day) plus lifestyle measures or b) only lifestyle measures. Recruitment will be completed within one year. The reassessment of the patients will be done 3 months after starting of treatment. | Drug: Vitamin D 2200 IU/day |
| Active Comparator: Lifestyle measures | Behavioral: Lifestyle measures Diet and exercise |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 16 Years Да се 16 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Patients with metabolic syndrome (n = 50 adults) attending the Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina. Diagnosis of the Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III). Exclusion Criteria: - The study will exclude patients with triglyceride levels >500 mg/dL, - Diabetes mellitus, hypothyroidism (TSH >5 IU/mL), - Primary hyperparathyroidism, hypercalcemia of any cause, - A history of taking formulations of calcium or vitamin D, - Alcohol consumption >3 drinks per day for men and >2 drinks per day for women and women of childbearing age not taking contraceptive measures. - Patients with hypertension may be included in the study if their blood pressure is <140/90 and the antihypertensive treatment remains constant over the past 3 months (no change of antihypertensive medication during the study). - Finally, patients receiving lipid-lowering medicines or patients who have stopped taking them for less than 4 weeks will be excluded from the study. |
Резултат
Първични изходни мерки
1. Change in metabolic syndrome incidence 3 months after starting treatment [Baseline and 3 months]
Вторични изходни мерки
1. Change in levels of fasting glucose [Baseline and 3 months]
2. Change in levels of high-density lipoprotein cholesterol (HDL-C) [Baseline and 3 months]
3. Change in levels of blood pressure [Baseline and 3 months]
4. Changes in serum triglycerides [Baseline and 3 months]
5. Changes in levels of low-density lipoprotein cholesterol (LDL-C) [Baseline and 3 months]
6. Changes in levels of small dense low-density lipoprotein cholesterol (sdLDL-C) [Baseline and 3 months]
