Type 2 DiabetesPhase 1NCT01855321
Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes
A Phase 1 study testing Vitamin D in people with Type 2 Diabetes, run by University of Florida at 1 site in United States.
Trial summary
This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 2015
- Phase
- Phase 1
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes (per ADA criteria), on antihyperglycemic medications for at least 6 months and
- HbAlc value of 7.5%-10% 7-12%for at least 3 months prior to screening, and
- deficiency level of serum 25 (OH) Vitamin D i.e. below20 25 ng/mL at time of screening, but normal serum calcium values of 8.5-10.5mg/dL and
- on either angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blockade (ARB) antihypertensive medication
Who cannot join
- Any subjects with history of end-stage renal disease or frank proteinuria on urinalysis
- Any subjects with pregnancy at time of screening
- Any subjects with history of or current hypercalcemia (serum calcium > 10.5 mg/dL) or disease processes with underlying hypercalcemia pathology including hyperparathyroidism, nephrolithiasis, sarcoidosis, lung or bone malignancy
- Any subjects with diagnosis of Vitamin D deficiency or insufficiency, previously treated or currently treated with any form of prescription doses of either 1,25(OH)2D3 or 25(OH)D3 supplements exceeding 1000 IU/day
- Any subjects with malabsorption syndromes, nephrotic syndrome, or on medications that activate steroid or xenobiotic receptors which will interfere with absorption of Vitamin D supplements
- Any subjects with history of serious neurologic or psychiatric disorders that would interfere with the conduct or completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency.
Read the detailed description
Subject will undergo screening procedures, subject will have blood drawn from a vein in your arm to measure subject's Vitamin D level (about 1 tablespoon).If the subject is eligible based on the results of their blood work and the subject agrees to participate in this study, the subject will return to the clinic to begin the study. There will be 4 study visits every 2 months and phone interviews every 2 weeks during the 6 month study. In the beginning (Visit 1) and end of the study (Visit 4), fasting blood samples will be collected for analysis of fasting plasma glucose, %HbAlc (your long-term sugar control over a 3 month period), calcium, insulin, and Vitamin D level. Urine samples will be collected to determine urinary microalbumin-creatinine ratio (early protein loss in the kidneys). Blood pressure will be measured three times with an automatic blood pressure machine. Height and weight will be measured. A medical history questionnaire will be completed by subjects that will include basic demographics, typical dietary intake, smoking and alcohol history, medical history, as well as list of medications and over-the-counter supplements.
At Visit 1 the subject will be randomized (like the toss of a coin) to receive either a sugar pill or a high dose Vitamin D medication, which the subject will take once a week for 8 weeks and then once a month for 4 months. The subject will have a 50:50 chance of receiving one or the other pill. At Visit 2 and Visit 3, the subject will also get blood work to analyze your calcium and Vitamin D level. At each clinic visit, the subject will also have your blood sugar and high blood pressure managed closely by the study investigators, both of who are doctors (one being a primary care doctor and another being an endocrinology/diabetes doctor), according to a standardized preset flowchart.
This means that the doctors in this study will be controlling the subject's blood sugar and blood pressure values closely and may be changing the subject's blood pressure and/or your blood sugar medications during this study depending on what the subject's blood sugar and blood pressure values are. The subject will be instructed not to have their own primary care doctor or diabetes doctor adjust their diabetes or blood pressure as both will be managed closely by the study doctors during the entire 6 month study period. The subject doctors' will be sent a letter notifying of the subject's participation in the study and be instructed not to adjust any of the subject's blood sugar or blood pressure medications during the entire 6 month study as it will be done closely by the study doctors, as clinically indicated. The subject's doctor will be sent letters after each study visit detailing what changes were done, if any, to your blood sugar and blood pressure medication regimen. The subject will be interviewed on the phone every 2 weeks to assess for any medication adverse reactions and treatment compliance.
- Conditions
- Type 2 Diabetes
- Being tested
- Vitamin D, Placebo
- Keywords
- uncontrolled diabetes, vitamin D deficiency
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called cholecalciferol
The cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.
PlaceboDrug
The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of improvement in Glycemic control after Vitamin D therapy.
We will measure glycemic control as change in %HbAlc and fasting blood glucose after 9 months of Vitamin D therapy.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startAug 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Lo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855321
- Sponsor's protocol ID
- 174-2010
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2013
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01855321
- Acronym / sponsor ID
- 174-2010
- Conditions
- Type 2 Diabetes
- Keywords
- uncontrolled diabetes, vitamin D deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 May 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.
This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency.
Detailed description
Subject will undergo screening procedures, subject will have blood drawn from a vein in your arm to measure subject's Vitamin D level (about 1 tablespoon).If the subject is eligible based on the results of their blood work and the subject agrees to participate in this study, the subject will return to the clinic to begin the study. There will be 4 study visits every 2 months and phone interviews every 2 weeks during the 6 month study. In the beginning (Visit 1) and end of the study (Visit 4), fasting blood samples will be collected for analysis of fasting plasma glucose, %HbAlc (your long-term sugar control over a 3 month period), calcium, insulin, and Vitamin D level. Urine samples will be collected to determine urinary microalbumin-creatinine ratio (early protein loss in the kidneys). Blood pressure will be measured three times with an automatic blood pressure machine. Height and weight will be measured. A medical history questionnaire will be completed by subjects that will include basic demographics, typical dietary intake, smoking and alcohol history, medical history, as well as list of medications and over-the-counter supplements.
At Visit 1 the subject will be randomized (like the toss of a coin) to receive either a sugar pill or a high dose Vitamin D medication, which the subject will take once a week for 8 weeks and then once a month for 4 months. The subject will have a 50:50 chance of receiving one or the other pill. At Visit 2 and Visit 3, the subject will also get blood work to analyze your calcium and Vitamin D level. At each clinic visit, the subject will also have your blood sugar and high blood pressure managed closely by the study investigators, both of who are doctors (one being a primary care doctor and another being an endocrinology/diabetes doctor), according to a standardized preset flowchart.
This means that the doctors in this study will be controlling the subject's blood sugar and blood pressure values closely and may be changing the subject's blood pressure and/or your blood sugar medications during this study depending on what the subject's blood sugar and blood pressure values are. The subject will be instructed not to have their own primary care doctor or diabetes doctor adjust their diabetes or blood pressure as both will be managed closely by the study doctors during the entire 6 month study period. The subject doctors' will be sent a letter notifying of the subject's participation in the study and be instructed not to adjust any of the subject's blood sugar or blood pressure medications during the entire 6 month study as it will be done closely by the study doctors, as clinically indicated. The subject's doctor will be sent letters after each study visit detailing what changes were done, if any, to your blood sugar and blood pressure medication regimen. The subject will be interviewed on the phone every 2 weeks to assess for any medication adverse reactions and treatment compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin Dthe cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of type 2 diabetes (per ADA criteria), on antihyperglycemic medications for at least 6 months and
- HbAlc value of 7.5%-10% 7-12%for at least 3 months prior to screening, and
- deficiency level of serum 25 (OH) Vitamin D i.e. below20 25 ng/mL at time of screening, but normal serum calcium values of 8.5-10.5mg/dL and
- on either angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blockade (ARB) antihypertensive medication
Key exclusion criteria (6 listed)
- Any subjects with history of end-stage renal disease or frank proteinuria on urinalysis
- Any subjects with pregnancy at time of screening
- Any subjects with history of or current hypercalcemia (serum calcium > 10.5 mg/dL) or disease processes with underlying hypercalcemia pathology including hyperparathyroidism, nephrolithiasis, sarcoidosis, lung or bone malignancy
- Any subjects with diagnosis of Vitamin D deficiency or insufficiency, previously treated or currently treated with any form of prescription doses of either 1,25(OH)2D3 or 25(OH)D3 supplements exceeding 1000 IU/day
- Any subjects with malabsorption syndromes, nephrotic syndrome, or on medications that activate steroid or xenobiotic receptors which will interfere with absorption of Vitamin D supplements
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 DAlso: cholecalciferolThe cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. | Drug | Vitamin D |
| PlaceboThe placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months. | Drug | Placebo |
Primary outcome
Percentage of improvement in Glycemic control after Vitamin D therapy.
Time frame: 9 months
We will measure glycemic control as change in %HbAlc and fasting blood glucose after 9 months of Vitamin D therapy.
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 2015.
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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.
Margaret Lo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Type 2 Diabetes, run by University of Florida 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 4 inclusion and 6 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 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of improvement in Glycemic control after Vitamin D therapy. (time frame: 9 months). 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 2015.