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

August 17, 2011 updated by: University of Ioannina

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioannina, Greece, 45 110
        • Recruiting
        • Outpatient Lipid Clinic, University Hospital of Ioannina
        • Contact:
        • Sub-Investigator:
          • Evangelos Liberopoulos, MD
        • Sub-Investigator:
          • Stefania Makariou, MD
        • Sub-Investigator:
          • Anna Challa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • vitamin D
Active Comparator: Lifestyle measures
Behavioral: Lifestyle advice
Diet and exercise
Other Names:
  • Lifestyle measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in metabolic syndrome incidence 3 months after starting treatment
Time Frame: Baseline and 3 months
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in levels of fasting glucose
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in levels of high-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in levels of blood pressure
Time Frame: Baseline and 3 months
Baseline and 3 months
Changes in serum triglycerides
Time Frame: Baseline and 3 months
Baseline and 3 months
Changes in levels of low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline and 3 months
Baseline and 3 months
Changes in levels of small dense low-density lipoprotein cholesterol (sdLDL-C)
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Investigators

  • Principal Investigator: Moses Elisaf, MD, University of Ioannina Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (033)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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