ObesityPhase 2NCT00243256
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
A Phase 2 study testing Cholecalciferol in people with Obesity, run by University of Tromso at 1 site in Norway.
Trial summary
The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cholecalciferol
- How many people
- 450 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2005to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 30 - 40
- serum calcium < 2.55 mmol/L
Who cannot join
- serious diseases
- reduced kidney function
- renal stone disease
- using psychopharmaca
- using drugs for weight reduction
Trial locations and contacts
1 site in 1 country.
Norway1 site
Clinical Research Unit, University Hospital of North Norway
Tromsø, 9038
About this study
The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.
Read the detailed description
We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.
- Conditions
- Obesity
- Being tested
- Cholecalciferol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body composition
Measures of calcium metabolism
Insulin sensitivity
Muscle strength
Depression score
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startNov 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Investigators
- Rolf Jorde, Professor, Principal investigator, University of Tromsø, Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243256
- Sponsor's protocol ID
- CSEMDT-2005-2
- Status last verified
- May 2008
- First submitted
- 20 Oct 2005
- Last updated
- 14 May 2008
- Results posted
- No
Publications
Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.
PubMed 20056003
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
- ClinicalTrials.gov ID
- NCT00243256
- Acronym / sponsor ID
- CSEMDT-2005-2
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
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 evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.
Detailed description
We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 30 - 40
- serum calcium < 2.55 mmol/L
Key exclusion criteria (5 listed)
- serious diseases
- reduced kidney function
- renal stone disease
- using psychopharmaca
- using drugs for weight reduction
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 |
|---|---|---|
| Cholecalciferol | Drug | – |
Primary outcome
Body Weight
Body composition
Measures of calcium metabolism
Insulin sensitivity
Muscle strength
Depression score
Blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Derived from this study: PubMed 20056003Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.
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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.
Rolf Jorde, Professor principal investigator
University of Tromsø, Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Obesity, run by University of Tromso at 1 site in Norway.
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 2 inclusion and 5 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 14 May 2008. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Weight. The study lists 7 primary outcomes in all. 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 NCT00243256, 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 14 May 2008.