Vitamin D DeficiencyPhase 4NCT01153243
Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes
A Phase 4 study testing Ergocalciferol in people with Vitamin D Deficiency and Diabetes, run by Cook County Health.
Trial summary
Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitamin D Deficiency, Diabetes
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- African Americans
- DM type 2
Who cannot join
- symptomatic vitamin D deficiency
- hypocalcemia
- hypercalcemia
- malabsorption
- liver disease
- patients with creatinine > 1.5. (CKD >/= 3)
- pregnancy
About this study
Official title: Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.
Read the detailed description
Other questions in our study: In diabetic African American patients,
- Prevalence of vitamin D deficiency?
- Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers
Setting: All visits will take place at the Fantus Diabetes Clinic.
- Conditions
- Vitamin D Deficiency, Diabetes
- Being tested
- Ergocalciferol, Placebo pill
- Keywords
- inflammatory markers
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Drisdol, Vitamin D
Active Comparator: Ergocalciferol
The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
Placebo pillDrug
The investigators will give control group 12 weeks of 1 placebo pill every week.
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol | Active comparator | The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week) Receives: Drug: Ergocalciferol |
| Placebo pill | Placebo comparator | The investigators will give intervention group 12 weeks of placebo pill (in pill every week) Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory markers
Measured: baseline and 12 weeks
Secondary outcomes (1)
Levels of Vitamin D, PTH and Calcium
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startApr 2007
- Primary completionJun 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Rush University
- Investigators
- Leon Fogelfeld, MD, Study director, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153243
- Sponsor's protocol ID
- #07-061
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2010
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
- ClinicalTrials.gov ID
- NCT01153243
- Acronym / sponsor ID
- #07-061
- Conditions
- Vitamin D Deficiency, Diabetes
- Keywords
- inflammatory markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Rush University
- Study start
- Apr 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 30 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.
Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.
Detailed description
Other questions in our study: In diabetic African American patients,
- Prevalence of vitamin D deficiency?
- Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers
Setting: All visits will take place at the Fantus Diabetes Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol | Active comparator | Drug: ErgocalciferolThe investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week) |
| Placebo pill | Placebo comparator | Drug: Placebo pillThe investigators will give intervention group 12 weeks of placebo pill (in pill every week) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- African Americans
- DM type 2
Key exclusion criteria (7 listed)
- symptomatic vitamin D deficiency
- hypocalcemia
- hypercalcemia
- malabsorption
- liver disease
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 |
|---|---|---|
| ErgocalciferolAlso: Drisdol, Vitamin DActive Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week) | Drug | Ergocalciferol |
| Placebo pillThe investigators will give control group 12 weeks of 1 placebo pill every week. | Drug | Placebo pill |
Primary outcome
Levels of inflammatory markers
Time frame: baseline and 12 weeks
1 secondary outcome
Levels of Vitamin D, PTH and Calcium
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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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.
Leon Fogelfeld, MD study director
Cook County Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol in people with Vitamin D Deficiency and Diabetes, run by Cook County Health.
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: status not confirmed, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Levels of inflammatory markers (time frame: baseline and 12 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 7 Apr 2011.