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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D oil | Experimental | oil containing vitamin D (Vigantol oil) |
|
| placebo oil | Placebo Comparator | oil not containg vitamin D (Migliol oil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement | 6 drops of a vitamin D containing oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight From Baseline to 12 Months | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Mass From Baseline to 12 Months | baseline, 12 months | |
| Change in 25-hydroxyvitamin D From Baseline to 12 Months | baseline, 12 months | |
| Change in Calcitriol From Baseline to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heinrich Koertke, MD | Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Diabetes Center NRW | Bad Oeynhausen | North-Rhine Westfalia | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19321573 | Result | 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. |
| Label | URL |
|---|---|
| PMID: 17344484 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experiment | A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year. |
| FG001 | Placebo Comparator | A daily placebo oil is given for year |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experiment | A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year. |
| BG001 | Placebo Comparator | A daily placebo oil is given for year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight From Baseline to 12 Months | Posted | Mean | Standard Deviation | kg | baseline, 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experiment | A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Armin Zittermann | Heart and Diabetes Center North Rhine-Westfalia | +49 5731 97 | 1912 | azittermann@hdz-nrw.de |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| baseline, 12 months |
| Change in Parathyroid Hormone From Baseline to 12 Months | baseline, 12 months |
| Change in Triglycerides 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 |
| Change in Hb A1c From Baseline to 12 Months | change from baseline to 12 months |
| PMID: 16600341 | View source |
| PMID: 16197570 | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Change in Fat Mass From Baseline to 12 Months | Posted | Mean | Standard Deviation | kg | baseline, 12 months |
|
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| Secondary | Change in 25-hydroxyvitamin D From Baseline to 12 Months | Posted | Mean | Standard Deviation | nmol/l | baseline, 12 months |
|
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| Secondary | Change in Calcitriol From Baseline to 12 Months | Posted | Mean | Standard Deviation | pmol/l | baseline, 12 months |
|
|
|
| Secondary | Change in Parathyroid Hormone From Baseline to 12 Months | Posted | Mean | Standard Deviation | pmol/l | baseline, 12 months |
|
|
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| Secondary | Change in Triglycerides From Baseline to 12 Months | Posted | Mean | Standard Deviation | mmol/l | baseline, 12 months |
|
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| Secondary | Change in LDL-cholsterol From Baseline to 12 Months | Posted | Mean | Standard Deviation | mmol/l | baseline, 12 months |
|
|
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| Secondary | Change in C-reactive Protein From Baseline to 12 Months | Posted | Mean | Standard Deviation | mg/l | baseline, 12 months |
|
|
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| Secondary | Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months | Posted | Mean | Standard Deviation | pg/ml | baseline, 12 months |
|
|
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| Secondary | Change in Proinsulin From Baseline to 12 Months | Posted | Mean | Standard Deviation | pmol/l | baseline, 12 months |
|
|
|
| Secondary | Change in Hb A1c From Baseline to 12 Months | Posted | Mean | Standard Deviation | % glycosylated hemoglobin | change from baseline to 12 months |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Placebo Comparator | A daily placebo oil is given for year | 0 | 100 | 0 | 100 |
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| D013568 | Pathological Conditions, Signs and Symptoms |