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Vitamin D Effects in Overweight Patients (SMART)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
vitamin D
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring body weight, body compostion, vitamin D, blood pressure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Heart and Diabetes Center NRW

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin D oil

placebo oil

Arm Description

oil containing vitamin D (Vigantol oil)

oil not containg vitamin D (Migliol oil)

Outcomes

Primary Outcome Measures

Change in Body Weight From Baseline to 12 Months

Secondary Outcome Measures

Change in Fat Mass From Baseline to 12 Months
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Change in Calcitriol From Baseline to 12 Months
Change in Parathyroid Hormone From Baseline to 12 Months
Change in Triglycerides From Baseline to 12 Months
Change in LDL-cholsterol From Baseline to 12 Months
Change in C-reactive Protein From Baseline to 12 Months
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Change in Proinsulin From Baseline to 12 Months
Change in Hb A1c From Baseline to 12 Months

Full Information

First Posted
June 26, 2007
Last Updated
March 16, 2017
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT00493012
Brief Title
Vitamin D Effects in Overweight Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
body weight, body compostion, vitamin D, blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D oil
Arm Type
Experimental
Arm Description
oil containing vitamin D (Vigantol oil)
Arm Title
placebo oil
Arm Type
Placebo Comparator
Arm Description
oil not containg vitamin D (Migliol oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
6 drops of a vitamin D containing oil
Primary Outcome Measure Information:
Title
Change in Body Weight From Baseline to 12 Months
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in Fat Mass From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Calcitriol From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Parathyroid Hormone From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Triglycerides From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in LDL-cholsterol From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in C-reactive Protein From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Proinsulin From Baseline to 12 Months
Time Frame
baseline, 12 months
Title
Change in Hb A1c From Baseline to 12 Months
Time Frame
change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinrich Koertke, MD
Organizational Affiliation
Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart and Diabetes Center NRW
City
Bad Oeynhausen
State/Province
North-Rhine Westfalia
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19321573
Citation
Zittermann A, Frisch S, Berthold HK, Gotting 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: 10.3945/ajcn.2008.27004. Epub 2009 Mar 25.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PMID: 17344484
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PMID: 16600341
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PMID: 16197570

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Vitamin D Effects in Overweight Patients

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