Brief Summary
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
Brief Title
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Detailed Description
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Renal Insufficiency
Proteinuria
Eligibility Criteria
Inclusion Criteria:
* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L
Exclusion Criteria:
* On vitamin D in past 4 weeks
* Plans to relocate out of New York City in the next 6 months
* 25 (OH) Vitamin D level \<12.5 nmol/L
* HIV infection
* History of hypercalcemia or kidney stones
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* SBP \>160 DBP \>100 at screening visit
* Transplanted organ
* Cancer
* Polycystic kidney disease
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L
Exclusion Criteria:
* On vitamin D in past 4 weeks
* Plans to relocate out of New York City in the next 6 months
* 25 (OH) Vitamin D level \<12.5 nmol/L
* HIV infection
* History of hypercalcemia or kidney stones
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* SBP \>160 DBP \>100 at screening visit
* Transplanted organ
* Cancer
* Polycystic kidney disease
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Inclusion Criteria
Inclusion Criteria:
* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L
* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L
Gender
All
Gender Based
false
Keywords
Vitamin D
CKD
proteinuria
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01029002
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2007-266
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Primary Outcomes
Outcome Description
Urine albumin and creatinine were measured on spot urine specimens.
Outcome Measure
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
Outcome Time Frame
3 months
Secondary Ids
Secondary Id
K23DK078774
Secondary Outcomes
Outcome Description
25(OH) vitamin D levels were measured using liquid chromatography.
Outcome Time Frame
3 months
Outcome Measure
Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.
Outcome Time Frame
3 months
Outcome Measure
Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michal Melamed
Investigator Email
michal.melamed@einsteinmed.org
Investigator Phone
718-430-2304