Vitamin D DeficiencyPhase 4NCT01037140
Effects of Vitamin D Supplementation in Obesity
A Phase 4 study testing Cholecalciferol in people with Vitamin D Deficiency and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Obesity
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy obese (BMI 30 - 45 kg/m2)
- 25(OH) vitamin D < 50 nmol/l
Who cannot join
- Diabetes,
- Pregnancy or non-safe contraception,
- Vitamin D treatment within 3 months,
- Hypercalcaemia, renal failure,
- Liver failure, non eligibility for MRI-scan,
- Severe osteomalacia,
- Allergy towards study drug
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Aarhus
About this study
Official title: Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to the blood stream. In cell line studies as well as small clinical studies vitamin D has been shown to have the ability to reduce inflammation and cell growth.
In the present study the investigators wish to investigate the effect of vitamin D on fat-, muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol 175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated with placebo.
Read more
The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese subject will reduce inflammation and thereby reduce obesity-related complications.
The effect will be evaluated as follows:
- Levels of circulating inflammatory markers will be examined in blood samples collected prior to and after treatment.
- Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken before and after treatment.
- Effects on fat distribution will be evaluated by MRI scan before and after treatment.
- Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp performed on a subgroup of subjects with impaired fasting glucose.
- Effects on bone marrow density will be evaluated by DEXA scans before and after treatment.
- Effects on quality of life and depression score will be evaluated by questionnaires used before and after treatment.
- Conditions
- Vitamin D Deficiency, Obesity
- Being tested
- Cholecalciferol, placebo
- Medical subject headings
- Vitamin D Deficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called vitamin D
oral cholecalciferol tablets of 175 micrograms daily for 6 months
placeboDrug
oral placebo tablets similar to active comparator
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Active comparator | Not described Receives: Drug: Cholecalciferol |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on circulating inflammatory markers
Measured: 6 months
Secondary outcomes (7)
change in fat distribution
Measured: 6 months
change in insulin sensitivity
Measured: 6 months
change in bone mineral density
Measured: 6 months
change in quality of life
Measured: 6 months
change in depression score
Measured: 6 months
change in muscle function
Measured: 6 months
change in fat- and muscle metabolism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionJul 2012
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 Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Wamberg, Dr., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037140
- Sponsor's protocol ID
- 2008-005581-31
- Other IDs
- 2008
- Status last verified
- Aug 2012
- First submitted
- 8 Dec 2009
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
PubMed 35018442
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
- ClinicalTrials.gov ID
- NCT01037140
- Acronym / sponsor ID
- 2008-005581-31
- Conditions
- Vitamin D Deficiency, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Dec 2009 (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.
Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to the blood stream. In cell line studies as well as small clinical studies vitamin D has been shown to have the ability to reduce inflammation and cell growth.
In the present study the investigators wish to investigate the effect of vitamin D on fat-, muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol 175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated with placebo.
The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese subject will reduce inflammation and thereby reduce obesity-related complications.
The effect will be evaluated as follows:
- Levels of circulating inflammatory markers will be examined in blood samples collected prior to and after treatment.
- Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken before and after treatment.
- Effects on fat distribution will be evaluated by MRI scan before and after treatment.
- Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp performed on a subgroup of subjects with impaired fasting glucose.
- Effects on bone marrow density will be evaluated by DEXA scans before and after treatment.
- Effects on quality of life and depression score will be evaluated by questionnaires used before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholecalciferol | Active comparator | Drug: Cholecalciferol |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy obese (BMI 30 - 45 kg/m2)
- 25(OH) vitamin D < 50 nmol/l
Key exclusion criteria (7 listed)
- Diabetes,
- Pregnancy or non-safe contraception,
- Vitamin D treatment within 3 months,
- Hypercalcaemia, renal failure,
- Liver failure, non eligibility for MRI-scan,
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 |
|---|---|---|
| CholecalciferolAlso: vitamin Doral cholecalciferol tablets of 175 micrograms daily for 6 months | Drug | cholecalciferol |
| placebooral placebo tablets similar to active comparator | Drug | placebo |
Primary outcome
Effect on circulating inflammatory markers
Time frame: 6 months
7 secondary outcomes
change in fat distribution
Time frame: 6 months
change in insulin sensitivity
Time frame: 6 months
change in bone mineral density
Time frame: 6 months
change in quality of life
Time frame: 6 months
change in depression score
Time frame: 6 months
change in muscle function
Time frame: 6 months
change in fat- and muscle metabolism
Time frame: 6 months
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 2 Aug 2012.
- Derived from this study: PubMed 35018442Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
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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.
Louise Wamberg, Dr. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Vitamin D Deficiency and Obesity, run by University of Aarhus at 1 site in Denmark.
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 7 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 2 Aug 2012. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effect on circulating inflammatory markers (time frame: 6 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 NCT01037140, 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 2 Aug 2012.