Vitamin D Effects in Overweight Patients (SMART)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- Body Weight [ Time Frame: change in body weight from baseline to 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Germany | |
| 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 |
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 Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Vitamin D |
Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013