Vitamin D StatusNCT01798030
Vitamin D Retrospective Study and Role With Disease
An observational study of Vitamin D Status and Glucose Tolerance, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status, Glucose Tolerance, Blood Pressure
- What is being tested?
- Vitamin D
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2022
- Phase
- Observational
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: obese, older men and postmenopausal women
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk
Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Older people, individuals with high skin pigmentation, obese and sedentary individuals have low levels of Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical inactivity are associated with reduced exposure to sunlight, and obesity is associated with the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues that require its metabolic action. These conditions are also associated with heightened risk for developing type 2 diabetes, glucose intolerance, hypertension, and osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in older women who tend to have increased body fat, are more physically inactive and are at high risk for central obesity and its metabolic consequences of diabetes, hypertension and osteoporosis.
Read the detailed description
The heightened prevalence of obesity in aging especially in postmenopausal women suggests that interventions to raise Vitamin D levels might be preventive of these diseases. Investigators have completed studies of the effects of weight loss and exercise interventions in approximately 400 older women and men over the last 15 years, many of whom are obese. Investigators have data on glucose tolerance, blood pressure and bone density in these studies and stored plasma in which investigators can analyze Vitamin D levels. Vitamin D may be an important risk factor for these metabolic diseases and the availability of these samples for Vitamin D analysis will allow investigators to perform a cross-sectional study to address relationships of Vitamin D levels to glucose intolerance and diabetes, hypertension/blood pressure status, bone mineral density, the degree of obesity, and physical activity status measured as maximal aerobic capacity and accelerometry in these older men and women.
The results of this study have the potential to impact clinical practice in the prevention and treatment of diabetes, hypertension, and osteopenia/osteoporosis. This would circumvent the current dilemma for prevention of these chronic diseases through treatment of obesity, as these data would provide immediate prospects for changing the recommended doses of Vitamin D beneficial for reducing risk for these diseases.
The purpose of this study is to 1) determine the prevalence of Vitamin D deficiency in obese, older men and postmenopausal women and 2) the association of Vitamin D levels to glucose tolerance, blood pressure, bone mineral density, and hyperlipidemia, as well as association with Vitamin D receptor gene polymorphisms affecting metabolic responses to Vitamin D.
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Diabetes, Osteoporosis, Cardiovascular Risk
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
N/A, frozen specimen study
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Specimen analysis Receives: Other: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D
Vitamin D level ng/dl
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startNov 2009
- Primary completionNov 2021 (estimated)
- Study completionDec 2022 (estimated)
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 StatusStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alice S. Ryan, PhD, Baltimore VA Medical Center
- Investigators
- Alice S Ryan, PhD, Principal investigator, Baltimore VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798030
- Sponsor's protocol ID
- 43973
- Status last verified
- Jul 2021
- First submitted
- 21 Feb 2013
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sorkin JD, Vasaitis TS, Streeten E, Ryan AS, Goldberg AP. Evidence for threshold effects of 25-hydroxyvitamin D on glucose tolerance and insulin resistance in black and white obese postmenopausal women. J Nutr. 2014 May;144(5):734-42. doi: 10.3945/jn.114.190660. Epub 2014 Apr 9.
PubMed 24717362
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT01798030
- Acronym / sponsor ID
- 43973
- Keywords
- Vitamin D, Diabetes, Osteoporosis, Cardiovascular Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- Nov 2009
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Feb 2013 (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 D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Older people, individuals with high skin pigmentation, obese and sedentary individuals have low levels of Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical inactivity are associated with reduced exposure to sunlight, and obesity is associated with the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues that require its metabolic action. These conditions are also associated with heightened risk for developing type 2 diabetes, glucose intolerance, hypertension, and osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in older women who tend to have increased body fat, are more physically inactive and are at high risk for central obesity and its metabolic consequences of diabetes, hypertension and osteoporosis.
Detailed description
The heightened prevalence of obesity in aging especially in postmenopausal women suggests that interventions to raise Vitamin D levels might be preventive of these diseases. Investigators have completed studies of the effects of weight loss and exercise interventions in approximately 400 older women and men over the last 15 years, many of whom are obese. Investigators have data on glucose tolerance, blood pressure and bone density in these studies and stored plasma in which investigators can analyze Vitamin D levels. Vitamin D may be an important risk factor for these metabolic diseases and the availability of these samples for Vitamin D analysis will allow investigators to perform a cross-sectional study to address relationships of Vitamin D levels to glucose intolerance and diabetes, hypertension/blood pressure status, bone mineral density, the degree of obesity, and physical activity status measured as maximal aerobic capacity and accelerometry in these older men and women.
The results of this study have the potential to impact clinical practice in the prevention and treatment of diabetes, hypertension, and osteopenia/osteoporosis. This would circumvent the current dilemma for prevention of these chronic diseases through treatment of obesity, as these data would provide immediate prospects for changing the recommended doses of Vitamin D beneficial for reducing risk for these diseases.
The purpose of this study is to 1) determine the prevalence of Vitamin D deficiency in obese, older men and postmenopausal women and 2) the association of Vitamin D levels to glucose tolerance, blood pressure, bone mineral density, and hyperlipidemia, as well as association with Vitamin D receptor gene polymorphisms affecting metabolic responses to Vitamin D.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | – | Other: Vitamin DSpecimen analysis |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- obese, older men and postmenopausal women
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 DN/A, frozen specimen study | Other | Vitamin D |
Primary outcome
Vitamin D
Time frame: Day 1
Vitamin D level ng/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 24717362Sorkin JD, Vasaitis TS, Streeten E, Ryan AS, Goldberg AP. Evidence for threshold effects of 25-hydroxyvitamin D on glucose tolerance and insulin resistance in black and white obese postmenopausal women. J Nutr. 2014 May;144(5):734-42. doi: 10.3945/jn.114.190660. Epub 2014 Apr 9.
- 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.
Alice S Ryan, PhD principal investigator
Baltimore VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Status and Glucose Tolerance, run by Baltimore VA Medical Center 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2021. 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?
Results are not available in the source record.
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?
Vitamin D (time frame: Day 1). 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 NCT01798030, 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 20 Jul 2021.