Vitamin D Effects in Overweight Patients (SMART)

This study has been completed.
Sponsor:
Information provided by:
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT00493012
First received: June 26, 2007
Last updated: February 7, 2012
Last verified: May 2011
  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: vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of a Vitamin D (Cholecalciferol) Supplement on Body Composition, Blood Pressure, and Lipid and Diabetes Parameters in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Body Weight [ Time Frame: change in body weight from baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fat Mass [ Time Frame: parameter change from baseline to 12 months ] [ Designated as safety issue: No ]
  • 25-hydroxyvitamin D [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Calcitriol [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Parathyroid Hormone [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • LDL-cholsterol [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • C-reactive Protein [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Tumor Necrosis Factor Alpha [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Proinsulin [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
  • Hb A1c [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]

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
Experimental: vitamin D oil
oil containing vitamin D (Vigantol oil)
Dietary Supplement: vitamin D
6 drops of a vitamin D containing oil
Placebo Comparator: placebo oil
oil not containg vitamin D (Migliol oil)
Dietary Supplement: vitamin D
6 drops of a vitamin D containing oil

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 vitamin D supplement 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. Dietary 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
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: NCT00493012

Locations
Germany
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

Additional Information:
Publications:
Responsible Party: Heinrich Körtke, Heart Center North-Rhine Westfalia, Germany
ClinicalTrials.gov Identifier: NCT00493012     History of Changes
Other Study ID Numbers: 001
Study First Received: June 26, 2007
Results First Received: March 29, 2011
Last Updated: February 7, 2012
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

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Overnutrition
Nutrition Disorders
Signs and Symptoms
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014