Vitamin D Effects in Overweight Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Detailed Description

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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 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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vitamin D oil

oil containing vitamin D (Vigantol oil)

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

6 drops of a vitamin D containing oil

placebo oil

oil not containg vitamin D (Migliol oil)

Group Type PLACEBO_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

6 drops of a vitamin D containing oil

Interventions

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vitamin D

6 drops of a vitamin D containing oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes