Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01237769
• Other study ID #: 003
• Status: Unknown status
• Phase: Phase 4
• First received: November 9, 2010
• Last updated: August 17, 2011
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2010
• Source: University of Ioannina
• Contact: Moses Elisaf, MD
• Phone: +302651007509
• Email: egepi[@]cc.uoi.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years emphasis has been given to investigate the role of vitamin D in areas beyond bone metabolism and maintenance of calcium homeostasis. Thus, vitamin D deficiency has been associated with risk factors for the occurrence of cardiovascular disease as well as with overall mortality.In addition, there are indications that a large proportion of the population (up to 50%) is vitamin D deficient. The measurement of vitamin 25 (OH) D3 levels is the best way to estimate the vitamin D actual reserves. It is worth mentioning that elevated levels of parathyroid hormone (PTH) [5] and reduced levels of 1,25 (OH)2 vitamin D3 (calcitriol have also been associated with cardiovascular disease.

The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in approximately 25% of the Greek population.There are a lot of data linking low vitamin D levels with the metabolic syndrome as a whole as well as with its individual characteristics. Specifically, vitamin D deficiency has been associated with increased incidence of hypertension, dyslipidemia, obesity, inflammation and dysglycemia.

Many studies have explored the effect of giving vitamin D supplements on the risk factors associated with the metabolic syndrome and the cardiovascular disease. The results of these studies are conflicting and this may partially be due to different doses of vitamin D used. The form of vitamin D most commonly used in these studies is cholecalciferol (vitamin D3.

Aim of the study:

Determination of the effect of cholecalciferol (VitD3) (2200 IU/day) on metabolic parameters in patients with metabolic syndrome.

Endpoints:

The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting treatment:

• Waist circumference

• Blood pressure

• Levels of fasting serum triglycerides

• Levels of high-density lipoprotein cholesterol (HDL-C)

• Levels of fasting serum glucose.

The secondary endpoints will include changes in:

• The levels of low-density lipoprotein cholesterol (LDL-C) and non-HDL-C

• Subfractions of LDL-C [average particle size of LDL-C, levels of small dense (sd) LDL-C]

• Subfractions of HDL-C (levels of small and large particle HDL-C)

• The activity and levels of Lp-PLA2 (lipoprotein-associated phospholipase A2)

• The levels of serum apolipoprotein AI, A-II, AV, B, E, C-II, C-III and lipoprotein (Lp) (a)

• The activity of paraoxonase-1 (PON1)

• The concentration of pre-beta1-HDL

• The levels of hs-CRP (high sensitivity C-reactive protein)

• Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and oxidized LDL (oxLDL)

• Adipokine levels (leptin, adiponectin, visfatin)

• Glucose homeostasis (index HOMA: fasting insulin X fasting glucose/405)

• The levels of glycosylated hemoglobin (HbA1c)

• The levels of 25 (OH) vitamin D3, of 1,25 (OH)2 vitamin D3 and PTH

• The levels of serum electrolytes (Ca, PO4) and the activity of alkaline phosphatase (ALP) in serum.

Study population:

The investigators will study 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Vitamin D3
2200 IU/day

Behavioral:
• Lifestyle advice
Diet and exercise

Locations

Country	Name	City	State
Greece	Outpatient Lipid Clinic, University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic syndrome incidence 3 months after starting treatment		Baseline and 3 months
Secondary	Change in levels of fasting glucose		Baseline and 3 months
Secondary	Change in levels of high-density lipoprotein cholesterol (HDL-C)		Baseline and 3 months
Secondary	Change in levels of blood pressure		Baseline and 3 months
Secondary	Changes in serum triglycerides		Baseline and 3 months
Secondary	Changes in levels of low-density lipoprotein cholesterol (LDL-C)		Baseline and 3 months
Secondary	Changes in levels of small dense low-density lipoprotein cholesterol (sdLDL-C)		Baseline and 3 months

External Links

•   Link