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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
6 drops of a vitamin D containing oil
Heart and Diabetes Center NRW
Bad Oeynhausen, North-Rhine Westfalia, Germany
Change in Body Weight From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Fat Mass From Baseline to 12 Months
Time frame: baseline, 12 months
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Calcitriol From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Parathyroid Hormone From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Triglycerides From Baseline to 12 Months
Time frame: baseline, 12 months
Change in LDL-cholsterol From Baseline to 12 Months
Time frame: baseline, 12 months
Change in C-reactive Protein From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Proinsulin From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Hb A1c From Baseline to 12 Months
Time frame: change from baseline to 12 months
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