Vitamin D Effects in Overweight Patients

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: vitamin D

• Registration Number: NCT00493012
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief 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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2011-03-29
• Status Verified: 2011-05
• Results First Submitted QC: 2012-02-07
• Results First Posted: 2012-03-08
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo oil	vitamin D	oil not containg vitamin D (Migliol oil)
vitamin D oil	vitamin D	oil containing vitamin D (Vigantol oil)

Primary Outcome Measures

Name	Time	Method
Change in Body Weight From Baseline to 12 Months	baseline, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Calcitriol From Baseline to 12 Months	baseline, 12 months
Change in Parathyroid Hormone From Baseline to 12 Months	baseline, 12 months
Change in Fat Mass From Baseline to 12 Months	baseline, 12 months
Change in Triglycerides From Baseline to 12 Months	baseline, 12 months
Change in Hb A1c From Baseline to 12 Months	change from baseline to 12 months
Change in 25-hydroxyvitamin D From Baseline to 12 Months	baseline, 12 months
Change in LDL-cholsterol From Baseline to 12 Months	baseline, 12 months
Change in C-reactive Protein From Baseline to 12 Months	baseline, 12 months
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months	baseline, 12 months
Change in Proinsulin From Baseline to 12 Months	baseline, 12 months

Trial Locations

Locations (1)

Heart and Diabetes Center NRW; 🇩🇪 Bad Oeynhausen, North-Rhine Westfalia, Germany