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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


Phase 4
18 Years
70 Years
Not Enrolling
Both
Overweight, Obesity

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Body Weight

Outcome Time Frame:

change in body weight from baseline to 12 months

Safety Issue:

No

Principal Investigator

Heinrich Koertke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

001

NCT ID:

NCT00493012

Start Date:

January 2006

Completion Date:

December 2007

Related Keywords:

  • Overweight
  • Obesity
  • body weight
  • body compostion
  • vitamin D
  • blood pressure
  • Obesity
  • Overweight

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