Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493012
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2007-06-26
Brief Title:
Vitamin D Effects in Overweight Patients
Sponsor:
Heart and Diabetes Center North-Rhine Westfalia
Organization:
Heart and Diabetes Center North-Rhine Westfalia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
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
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 andor dietary calcium may influence energy metabolism and body weight We therefore perform a prospective controlled trial with 200 overweight Body mass index 27-299 kgm2 and obese subjects Body mass index 30 kgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None