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Vitamin D Effects in Overweight Patients (SMART)
This study has been completed.
Sponsored by: Heart and Diabetes Center North-Rhine Westfalia
Information provided by: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT00493012
  Purpose

The purpose of the study is to investigate in overweight patients who are on a telemedically guided weight loss program the influence of a daily vitamin D supplement on

  • weight loss and body composition,
  • selected inflammation markers and biochemical parameters of lipid and glucose metabolism .
  • selected clinical parameters such as blood pressure, heart rate

Condition Intervention Phase
Overweight
Obesity
Dietary Supplement: cholecalciferol
Phase IV

MedlinePlus related topics: Diabetes Dietary Supplements Obesity Weight Control
Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Effects of a Vitamin D Supplement on Body Composition, Blood Pressure, and Lipid and Diabetes Parameters in Overweight Patients Taking Part in a Telemedically Guided Weight Loss Program

Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • body weight and body composition (fat mass, fat free mass) [ Time Frame: baseline, and after 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inflammation markers, parameters of lipid and glucose metabolism, calciotropic hormones, serum calcium, heart rate, blood pressure, calciotropic hormones [ Time Frame: baseline, and after 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
vitamin D supplement versus placebo
Dietary Supplement: cholecalciferol
83.3 µg daily for 1 year as oel

Detailed Description:

Obese patients are known to have low levels of vitamin D metabolites. There is some evidence that vitamin D and/or dietary calcium may influence energy metabolism and body weight. We therefore perform a prospective controlled trial with 200 overweight (Body mass index 27-29.9 kg/m2) and obese subjects (Body mass index >= 30 kg/m2) who are on a telemedically guided weight loss program. Subjects randomly receive a daily cholecalciferol supplement of 83.3μg or a placebo for 1 year. Participants have to send their body weight data to the study office weekly. In addition, a nutritionist at the study office has to be contacted weekly to receive further support concerning the weight loss program. Dieatry records have to be completed monthly. Clinical parameters and blood samples are collected at baseline, and after 6 and 12 months. It is the aim of the study to investigate the vitamin D effects on weight loss and body composition. In addition, possible vitamin D effects on clinical and selected biochemical parameters should be assessed. These parameters include heart rate, blood pressure, inflammation markers, and parameters of lipid and glucose metablolism.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index > 27 kg/m2

Exclusion Criteria:

  • pregnant and lactating women
  • vegetarians
  • patients with renal insufficiency (creatinine > 1.5 mg/dl)
  • History of renal stones and gallstones
  • patients with insulin dependent diabetes mellitus
  • parallel participation in another clinical study
  • missing informed consent
  • subjects with pacemaker implantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493012

Locations
Germany, North-Rhine Westfalia
Heart and Diabetes Center NRW
Bad Oeynhausen, North-Rhine Westfalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Principal Investigator: Heinrich Koertke, MD Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
  More Information

PMID: 17344484  This link exits the ClinicalTrials.gov site
PMID: 16600341  This link exits the ClinicalTrials.gov site
PMID: 16197570  This link exits the ClinicalTrials.gov site

Responsible Party: Heart Center North-Rhine Westfalia, Germany ( Heinrich Körtke )
Study ID Numbers: 001
Study First Received: June 26, 2007
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00493012  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
body weight
body compostion
vitamin D
blood pressure

Study placed in the following topic categories:
Body Weight
Cholecalciferol
Signs and Symptoms
Obesity
Vitamin D
Weight Loss
Ergocalciferols
Diabetes Mellitus
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009