Vitamin D Effects in Overweight Patients

Obesity Clinical Trial

— SMART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493012
• Other study ID #: 001
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2007
• Last updated: February 7, 2012
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2011
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Intervention

Dietary Supplement:
• vitamin D
6 drops of a vitamin D containing oil

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center NRW	Bad Oeynhausen	North-Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zittermann A, Frisch S, Berthold HK, Götting C, Kuhn J, Kleesiek K, Stehle P, Koertke H, Koerfer R. Vitamin D supplementation enhances the beneficial effects of weight loss on cardiovascular disease risk markers. Am J Clin Nutr. 2009 May;89(5):1321-7. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		change in body weight from baseline to 12 months	No
Secondary	Fat Mass		parameter change from baseline to 12 months	No
Secondary	25-hydroxyvitamin D		change from baseline to 12 months	No
Secondary	Calcitriol		change from baseline to 12 months	No
Secondary	Parathyroid Hormone		change from baseline to 12 months	No
Secondary	Triglycerides		change from baseline to 12 months	No
Secondary	LDL-cholsterol		change from baseline to 12 months	No
Secondary	C-reactive Protein		change from baseline to 12 months	No
Secondary	Tumor Necrosis Factor Alpha		change from baseline to 12 months	No
Secondary	Proinsulin		change from baseline to 12 months	No
Secondary	Hb A1c		change from baseline to 12 months	No

External Links

•   PMID: 16197570
•   PMID: 16600341
•   PMID: 17344484