Vitamin D Effects in Overweight Patients (SMART)

Heart and Diabetes Center North-Rhine Westfalia

Status: Completed

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00493012

001

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

vitamin D oil

Experimental group

Description:

oil containing vitamin D (Vigantol oil)

Treatment:

Dietary Supplement: vitamin D

placebo oil

Placebo Comparator group

Description:

oil not containg vitamin D (Migliol oil)

Treatment:

Dietary Supplement: vitamin D