Vitamin D Effects in Overweight Patients — SMART  

Obesity Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

• NCT number: NCT00493012
• Study type: Interventional
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Completion date: December 2007