Diabetic Kidney DiseaseNCT01214356
Impact of Vitamin D on Diabetic Kidney Disease in African Americans
A study testing Vitamin D3 in people with Diabetic Kidney Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American race
- Diagnosis of Type 2 Diabetes
- Stage 1 or 2 Kidney Disease with detectable microalbuminuria >4.0 (mg/g) 25(OH)D level <20 ng/ml
Who cannot join
- Type 1 diabetes
- --> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis
- Unable to provide informed consent or contact information
- Pre-existing calcium or parathyroid condition, including serum calcium >10.2 mg/dL
- Sarcoidosis, active tuberculosis, or malignancy
- Known hypersensitivity to vitamin D or any of its analogues and derivatives
- Current pregnancy or planning to become pregnant in next 15 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes.
Read the detailed description
Diabetic kidney disease is increasing in prevalence and is associated with significant morbidity and mortality. Health disparities exist in the progression of diabetic kidney disease, with minorities being more affected even when adjusting for treatment, glycemic and hypertensive control, and medical coverage. Secondary prevention of the progression of diabetic kidney disease is hindered by a lack of easily modifiable risk factors. Based on animal and observational human studies, vitamin D deficiency is potentially a novel, modifiable risk factor that may interrupt or delay the progression of diabetic kidney disease through direct effects as well as by helping to ameliorate kidney disease risk factors, such as hyperglycemia, hypertension and inflammation. In addition, based on minorities having a higher prevalence of vitamin D deficiency, it may also potentially impact the differential progression of diabetic kidney disease in minorities. However, clinical trials evaluating the impact of vitamin D supplementation on diabetic kidney disease are lacking. Thus, this pilot study funded as an R03 through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the following specific aims: (1): To evaluate the impact of vitamin D supplementation (vitamin D3 at 400 IU/d versus 4000 IU/d) on the proportion of individuals with progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial. (2): To identify whether kidney disease risk factors such as blood pressure and glycemic control mediate the impact of vitamin D supplementation on the progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Vitamin D3
- Keywords
- diabetes, kidney disease, vitamin D
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Patients receive vitamin D 400 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
Vitamin D3Dietary supplement
Also called Cholecalciferol
Patients receive vitamin D 4000 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
| Study group | Role | What they receive |
|---|---|---|
| Lower Dose Vitamin D | Placebo comparator | Vitamin D3 supplementation of 400 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day Receives: Dietary Supplement: Vitamin D3 |
| Higher Dose Vitamin D | Active comparator | Vitamin D3 supplementation of 4000 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Albumin:Creatinine Ratio (ACR)
Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).
Measured: baseline and 6 months
Secondary outcomes (1)
Decrease in Estimated Glomerular Filtration Rate (eGFR)
Estimated Glomerular Filtration Rate (eGFR) will be evaluated every 6 months, since changes in eGFR and ACR may occur independently and represent different pathways to the development of renal insufficiency. eGFR will be calculated via the Modification of Diet in Renal Disease (MDRD) equation of 4 variables (Cr level, age, sex, race) per NKF recommendations, with serum creatinine (Cr) measured using the SYNCHRON® System by means of the Jaffe rate method. For the purposes of this study, a decrease in eGFR will serve as a secondary outcome measure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa A Diaz, MD, MS, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214356
- Sponsor's protocol ID
- 1R03DK089120
- Status last verified
- Sep 2018
- First submitted
- 1 Oct 2010
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D on Diabetic Kidney Disease in African Americans
- ClinicalTrials.gov ID
- NCT01214356
- Acronym / sponsor ID
- 1R03DK089120
- Conditions
- Diabetic Kidney Disease
- Keywords
- diabetes, kidney disease, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes.
Detailed description
Diabetic kidney disease is increasing in prevalence and is associated with significant morbidity and mortality. Health disparities exist in the progression of diabetic kidney disease, with minorities being more affected even when adjusting for treatment, glycemic and hypertensive control, and medical coverage. Secondary prevention of the progression of diabetic kidney disease is hindered by a lack of easily modifiable risk factors. Based on animal and observational human studies, vitamin D deficiency is potentially a novel, modifiable risk factor that may interrupt or delay the progression of diabetic kidney disease through direct effects as well as by helping to ameliorate kidney disease risk factors, such as hyperglycemia, hypertension and inflammation. In addition, based on minorities having a higher prevalence of vitamin D deficiency, it may also potentially impact the differential progression of diabetic kidney disease in minorities. However, clinical trials evaluating the impact of vitamin D supplementation on diabetic kidney disease are lacking. Thus, this pilot study funded as an R03 through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the following specific aims: (1): To evaluate the impact of vitamin D supplementation (vitamin D3 at 400 IU/d versus 4000 IU/d) on the proportion of individuals with progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial. (2): To identify whether kidney disease risk factors such as blood pressure and glycemic control mediate the impact of vitamin D supplementation on the progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Dose Vitamin D | Placebo comparator | Dietary Supplement: Vitamin D3Vitamin D3 supplementation of 400 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day |
| Higher Dose Vitamin D | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 supplementation of 4000 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American race
- Diagnosis of Type 2 Diabetes
- Stage 1 or 2 Kidney Disease with detectable microalbuminuria >4.0 (mg/g) 25(OH)D level <20 ng/ml
Key exclusion criteria (7 listed)
- Type 1 diabetes
- --> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis
- Unable to provide informed consent or contact information
- Pre-existing calcium or parathyroid condition, including serum calcium >10.2 mg/dL
- Sarcoidosis, active tuberculosis, or malignancy
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 D3Also: CholecalciferolPatients receive vitamin D 400 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up) | Dietary supplement | Lower Dose Vitamin D |
| Vitamin D3Also: CholecalciferolPatients receive vitamin D 4000 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up) | Dietary supplement | Higher Dose Vitamin D |
Primary outcome
Change in Urinary Albumin:Creatinine Ratio (ACR)
Time frame: baseline and 6 months
Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).
1 secondary outcome
Decrease in Estimated Glomerular Filtration Rate (eGFR)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vanessa A Diaz, MD, MS principal investigator
Medical University of South Carolina
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 in people with Diabetic Kidney Disease, run by Medical University of South Carolina 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 3 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: finished, as of the sponsor's last update on 16 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Urinary Albumin:Creatinine Ratio (ACR) (time frame: baseline and 6 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 16 Oct 2018.