OverweightSMARTNCT00493012
Vitamin D Effects in Overweight Patients
A study testing vitamin D in people with Overweight and Obesity, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index > 27 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Center NRW
Bad Oeynhausen, North-Rhine Westfalia, 32545
About this study
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
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
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- vitamin D
- Keywords
- body weight, body compostion, vitamin D, blood pressure
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
6 drops of a vitamin D containing oil
| Study group | Role | What they receive |
|---|---|---|
| vitamin D oil | Experimental | oil containing vitamin D (Vigantol oil) Receives: Dietary Supplement: vitamin D |
| placebo oil | Placebo comparator | oil not containg vitamin D (Migliol oil) Receives: Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight From Baseline to 12 Months
Measured: baseline, 12 months
Secondary outcomes (10)
Change in Fat Mass From Baseline to 12 Months
Measured: baseline, 12 months
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Measured: baseline, 12 months
Change in Calcitriol From Baseline to 12 Months
Measured: baseline, 12 months
Change in Parathyroid Hormone From Baseline to 12 Months
Measured: baseline, 12 months
Change in Triglycerides From Baseline to 12 Months
Measured: baseline, 12 months
Change in LDL-cholsterol From Baseline to 12 Months
Measured: baseline, 12 months
Change in C-reactive Protein From Baseline to 12 Months
Measured: baseline, 12 months
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Measured: baseline, 12 months
Change in Proinsulin From Baseline to 12 Months
Measured: baseline, 12 months
Change in Hb A1c From Baseline to 12 Months
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heinrich Koertke, MD, Principal investigator, Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493012
- Sponsor's protocol ID
- 001
- Acronym
- SMART
- Status last verified
- May 2011
- First submitted
- 26 Jun 2007
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19321573
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00493012
- Acronym / sponsor ID
- SMART / 001
- Conditions
- Overweight, Obesity
- Keywords
- body weight, body compostion, vitamin D, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 8 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D oil | Experimental | Dietary Supplement: vitamin Doil containing vitamin D (Vigantol oil) |
| placebo oil | Placebo comparator | Dietary Supplement: vitamin Doil not containg vitamin D (Migliol oil) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index > 27 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D6 drops of a vitamin D containing oil | Dietary supplement | placebo oil, vitamin D oil |
Primary outcome
Change in Body Weight From Baseline to 12 Months
Time frame: baseline, 12 months
10 secondary outcomes
Change in Fat Mass From Baseline to 12 Months
Time frame: baseline, 12 months
Change in 25-hydroxyvitamin D From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Calcitriol From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Parathyroid Hormone From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Triglycerides From Baseline to 12 Months
Time frame: baseline, 12 months
Change in LDL-cholsterol From Baseline to 12 Months
Time frame: baseline, 12 months
Change in C-reactive Protein From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Proinsulin From Baseline to 12 Months
Time frame: baseline, 12 months
Change in Hb A1c From Baseline to 12 Months
Time frame: change from baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19321573Zittermann 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.
- PMID: 17344484Link provided by the sponsor.
- PMID: 16600341Link provided by the sponsor.
- PMID: 16197570Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich Koertke, MD principal investigator
Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Overweight and Obesity, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight From Baseline to 12 Months (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.