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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Body Weight
change in body weight from baseline to 12 months
No
Heinrich Koertke, MD
Principal Investigator
Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
Germany: Federal Institute for Drugs and Medical Devices
001
NCT00493012
January 2006
December 2007
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