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Sponsored by: |
Heart and Diabetes Center North-Rhine Westfalia |
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Information provided by: | Heart and Diabetes Center North-Rhine Westfalia |
ClinicalTrials.gov Identifier: | NCT00493012 |
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
Condition | Intervention | Phase |
---|---|---|
Overweight Obesity |
Dietary Supplement: cholecalciferol |
Phase IV |
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 |
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 |
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1: Experimental
vitamin D supplement versus placebo
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Dietary Supplement: cholecalciferol
83.3 µg daily for 1 year as oel
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, North-Rhine Westfalia | |
Heart and Diabetes Center NRW | |
Bad Oeynhausen, North-Rhine Westfalia, Germany, 32545 |
Principal Investigator: | Heinrich Koertke, MD | Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany |
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 |
body weight body compostion vitamin D blood pressure |
Body Weight Cholecalciferol Signs and Symptoms Obesity Vitamin D Weight Loss |
Ergocalciferols Diabetes Mellitus Nutrition Disorders Overnutrition Overweight |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |