ObesityWeightNCT01013584
The Effect of Weight on Vitamin D Dose Response
A study testing cholecalciferol in people with Obesity and Vitamin D Deficiency, run by Creighton University at 1 site in United States.
Trial summary
Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2011
- Phase
- Interventional
- 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 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men aged 19 to 60 with BMI > 30.0.
- They will have low (<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods)
Who cannot join
- Subjects will not have history of hepatic or renal disease.
- Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids.
- They will not be on hydrochlorothiazide medications which could cause hypercalcemia.
- They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries.
- Pregnancy is also an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. It is especially common in northern countries with long winters due to inadequate sun exposure during winter. In the US, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research indicates that obesity is associated with a low vitamin D3 level.
Read the detailed description
Obesity is a known risk factor for vitamin D deficiency. Adequate levels of vitamin D are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. Current FDA recommendations for vitamin D intake do not differentiate between lean and obese people. There are no published studies indicating if the 25(OH)D response to a given daily dose of vitamin D is any less in an obese person than a normal weight person. The purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (OH)D concentration in obese subjects. Data obtained in this study will be compared to published normative data for non-obese subjects. Recommendations will be provided for optimal treatment of vitamin D deficiency in obese men and women.
- Conditions
- Obesity, Vitamin D Deficiency
- Being tested
- cholecalciferol
- Keywords
- vitamin D
- Medical subject headings
- Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
daily dose
| Study group | Role | What they receive |
|---|---|---|
| 1,000 IU | Active comparator | 1,000 IU/day of vitamin D3 Receives: Dietary Supplement: cholecalciferol |
| 5,000 IU | Active comparator | 5,000 IU/day of vitamin D3 Receives: Dietary Supplement: cholecalciferol |
| 10,000 IU | Active comparator | 10,000 IU/day of vitamin D3 Receives: Dietary Supplement: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andjela Drincic, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013584
- Sponsor's protocol ID
- Creighton 8
- Acronym
- Weight
- Status last verified
- Jun 2012
- First submitted
- 12 Nov 2009
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight on Vitamin D Dose Response
- ClinicalTrials.gov ID
- NCT01013584
- Acronym / sponsor ID
- Weight / Creighton 8
- Conditions
- Obesity, Vitamin D Deficiency
- Keywords
- vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Nov 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.
Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. It is especially common in northern countries with long winters due to inadequate sun exposure during winter. In the US, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research indicates that obesity is associated with a low vitamin D3 level.
Detailed description
Obesity is a known risk factor for vitamin D deficiency. Adequate levels of vitamin D are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. Current FDA recommendations for vitamin D intake do not differentiate between lean and obese people. There are no published studies indicating if the 25(OH)D response to a given daily dose of vitamin D is any less in an obese person than a normal weight person. The purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (OH)D concentration in obese subjects. Data obtained in this study will be compared to published normative data for non-obese subjects. Recommendations will be provided for optimal treatment of vitamin D deficiency in obese men and women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1,000 IU | Active comparator | Dietary Supplement: cholecalciferol1,000 IU/day of vitamin D3 |
| 5,000 IU | Active comparator | Dietary Supplement: cholecalciferol5,000 IU/day of vitamin D3 |
| 10,000 IU | Active comparator | Dietary Supplement: cholecalciferol10,000 IU/day of vitamin D3 |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men aged 19 to 60 with BMI > 30.0.
- They will have low (<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods)
Key exclusion criteria (5 listed)
- Subjects will not have history of hepatic or renal disease.
- Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids.
- They will not be on hydrochlorothiazide medications which could cause hypercalcemia.
- They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries.
- Pregnancy is also an exclusion criterion.
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 |
|---|---|---|
| cholecalciferoldaily dose | Dietary supplement | 1,000 IU, 10,000 IU, 5,000 IU |
Primary outcome
To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
Time frame: 21 weeks
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 26 Jun 2012.
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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.
Andjela Drincic, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Obesity and Vitamin D Deficiency, run by Creighton University at 1 site in United States.
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 26 Jun 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 United States. 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.
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?
To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women. (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2012.