Type 2 DiabetesAVISNCT01141192
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
A study testing vitamin D3, cholecalciferol and Inactive comparator in people with Type 2 Diabetes, run by Augusta University at 1 site in United States.
Trial summary
Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- vitamin D3, cholecalciferol and Inactive comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- African American by self-report
- In good health
Who cannot join
- Diagnosis of diabetes
- Health problems/medication affecting calcium and/or vitamin D metabolism
- Current use of vitamin/mineral/herbal/nutritional supplements
- Inability to swallow pills
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, \& insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar \& blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.
The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.
Read the detailed description
Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.
- Conditions
- Type 2 Diabetes
- Being tested
- vitamin D3, cholecalciferol, Inactive comparator
- Keywords
- vitamin D status, 25-OH D, ionized calcium, fasting glucose, hemoglobin A1c, fasting insulin, glucose metabolism, HOMA index, blood lipids, type 2 diabetes, PTH, adiposity, body fat percentage, dual energy x-ray absorptiometry, pulse wave velocity, arterial stiffness, flow-mediated dilation, African American, inflammatory markers
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3, cholecalciferolDietary supplement
1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.
Inactive comparatorDietary supplement
The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplement | Active comparator | 60,000 IU vitamin D3 oral supplement provided every four weeks at weeks 0, 4, 8, and 12 in the form of one 50,000 and two 5,000 IU vitamin D3 supplements in gelcap form. Receives: Dietary Supplement: vitamin D3, cholecalciferol |
| Sugar Pill | Placebo comparator | Inactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12. Receives: Dietary Supplement: Inactive comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.
Measured: 16 weeks
Secondary outcomes (1)
Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Investigators
- Yanbin Dong, MD, PhD, Study director, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141192
- Sponsor's protocol ID
- 0910091
- Acronym
- AVIS
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu E, Meigs JB, Pittas AG, McKeown NM, Economos CD, Booth SL, Jacques PF. Plasma 25-hydroxyvitamin d is associated with markers of the insulin resistant phenotype in nondiabetic adults. J Nutr. 2009 Feb;139(2):329-34. doi: 10.3945/jn.108.093831. Epub 2008 Dec 23.
PubMed 19106328Pittas AG, Dawson-Hughes B. Vitamin D and diabetes. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):425-9. doi: 10.1016/j.jsbmb.2010.03.042. Epub 2010 Mar 18.
PubMed 20304061Voidonikola PT, Stamatelopoulos KS, Alevizaki M, Kollias GE, Zakopoulos NA, Lekakis JP, Anastasiou E, Theodorakis MJ, Pittas AG, Papamichael CM. The association between glycemia and endothelial function in nondiabetic individuals: the importance of body weight. Obesity (Silver Spring). 2008 Dec;16(12):2658-62. doi: 10.1038/oby.2008.431. Epub 2008 Oct 9.
PubMed 18846051Liu E, Meigs JB, Pittas AG, Economos CD, McKeown NM, Booth SL, Jacques PF. Predicted 25-hydroxyvitamin D score and incident type 2 diabetes in the Framingham Offspring Study. Am J Clin Nutr. 2010 Jun;91(6):1627-33. doi: 10.3945/ajcn.2009.28441. Epub 2010 Apr 14.
PubMed 20392893Zhu H, Guo D, Li K, Pedersen-White J, Stallmann-Jorgensen IS, Huang Y, Parikh S, Liu K, Dong Y. Increased telomerase activity and vitamin D supplementation in overweight African Americans. Int J Obes (Lond). 2012 Jun;36(6):805-9. doi: 10.1038/ijo.2011.197. Epub 2011 Oct 11.
PubMed 21986705
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
- ClinicalTrials.gov ID
- NCT01141192
- Acronym / sponsor ID
- AVIS / 0910091
- Conditions
- Type 2 Diabetes
- Keywords
- vitamin D status, 25-OH D, ionized calcium, fasting glucose, hemoglobin A1c, fasting insulin, glucose metabolism, HOMA index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Jun 2010 (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.
Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, \& insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar \& blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.
The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.
Detailed description
Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplement | Active comparator | Dietary Supplement: vitamin D3, cholecalciferol60,000 IU vitamin D3 oral supplement provided every four weeks at weeks 0, 4, 8, and 12 in the form of one 50,000 and two 5,000 IU vitamin D3 supplements in gelcap form. |
| Sugar Pill | Placebo comparator | Dietary Supplement: Inactive comparatorInactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- African American by self-report
- In good health
Key exclusion criteria (5 listed)
- Diagnosis of diabetes
- Health problems/medication affecting calcium and/or vitamin D metabolism
- Current use of vitamin/mineral/herbal/nutritional supplements
- Inability to swallow pills
- Pregnancy
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 D3, cholecalciferol1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study. | Dietary supplement | Vitamin D3 supplement |
| Inactive comparatorThe inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3 | Dietary supplement | Sugar Pill |
Primary outcome
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.
Time frame: 16 weeks
1 secondary outcome
Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity
Time frame: 16 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 10 Jun 2010.
- Background: PubMed 19106328Liu E, Meigs JB, Pittas AG, McKeown NM, Economos CD, Booth SL, Jacques PF. Plasma 25-hydroxyvitamin d is associated with markers of the insulin resistant phenotype in nondiabetic adults. J Nutr. 2009 Feb;139(2):329-34. doi: 10.3945/jn.108.093831. Epub 2008 Dec 23.
- Background: PubMed 20304061Pittas AG, Dawson-Hughes B. Vitamin D and diabetes. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):425-9. doi: 10.1016/j.jsbmb.2010.03.042. Epub 2010 Mar 18.
- Background: PubMed 18846051Voidonikola PT, Stamatelopoulos KS, Alevizaki M, Kollias GE, Zakopoulos NA, Lekakis JP, Anastasiou E, Theodorakis MJ, Pittas AG, Papamichael CM. The association between glycemia and endothelial function in nondiabetic individuals: the importance of body weight. Obesity (Silver Spring). 2008 Dec;16(12):2658-62. doi: 10.1038/oby.2008.431. Epub 2008 Oct 9.
- Background: PubMed 20392893Liu E, Meigs JB, Pittas AG, Economos CD, McKeown NM, Booth SL, Jacques PF. Predicted 25-hydroxyvitamin D score and incident type 2 diabetes in the Framingham Offspring Study. Am J Clin Nutr. 2010 Jun;91(6):1627-33. doi: 10.3945/ajcn.2009.28441. Epub 2010 Apr 14.
- Derived from this study: PubMed 21986705Zhu H, Guo D, Li K, Pedersen-White J, Stallmann-Jorgensen IS, Huang Y, Parikh S, Liu K, Dong Y. Increased telomerase activity and vitamin D supplementation in overweight African Americans. Int J Obes (Lond). 2012 Jun;36(6):805-9. doi: 10.1038/ijo.2011.197. Epub 2011 Oct 11.
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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.
Yanbin Dong, MD, PhD study director
Augusta 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 vitamin D3, cholecalciferol and Inactive comparator in people with Type 2 Diabetes, run by Augusta 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 10 Jun 2010. 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. 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?
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?
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial. (time frame: 16 weeks). 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 NCT01141192, which also lists 5 linked publications.
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 10 Jun 2010.