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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Ioannina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT01237769
First received: November 9, 2010
Last updated: August 17, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Drug: Vitamin D3
Behavioral: Lifestyle advice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Change in metabolic syndrome incidence 3 months after starting treatment [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in levels of fasting glucose [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in levels of high-density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in levels of blood pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes in serum triglycerides [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes in levels of low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes in levels of small dense low-density lipoprotein cholesterol (sdLDL-C) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 D3
2200 IU/day
Other Name: vitamin D
Active Comparator: Lifestyle measures Behavioral: Lifestyle advice
Diet and exercise
Other Name: Lifestyle measures

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237769

Contacts
Contact: Moses Elisaf, MD +302651007509 egepi@cc.uoi.gr

Locations
Greece
Outpatient Lipid Clinic, University Hospital of Ioannina Recruiting
Ioannina, Greece, 45 110
Contact: Moses Elisaf, MD    +302651007509    egepi@cc.uoi.gr   
Sub-Investigator: Evangelos Liberopoulos, MD         
Sub-Investigator: Stefania Makariou, MD         
Sub-Investigator: Anna Challa, PhD         
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Moses Elisaf, MD University of Ioannina Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Moses Elisaf, University of Ioannina Medical School
ClinicalTrials.gov Identifier: NCT01237769     History of Changes
Other Study ID Numbers: 003
Study First Received: November 9, 2010
Last Updated: August 17, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Ioannina:
vitamin D
Metabolic syndrome
Hypertension
Dyslipidemia
Dysglycemia
Inflammation

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014