The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Proteinuria Clinical Trial

Official title:

The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029002
• Other study ID #: 2007-266
• Secondary ID: K23DK078774
• Status: Completed
• Phase: Phase 3
• Start date: October 2009
• Est. completion date: June 2014

Study information

• Verified date: August 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Kidney Diseases
• Proteinuria
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Vitamin D
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months

Other:
• Placebo
Patients randomized to this arm will receive one placebo pill once weekly.

Locations

Country	Name	City	State
United States	Montefiore medical center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.	Urine albumin and creatinine were measured on spot urine specimens.	3 months
Secondary	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.	25(OH) vitamin D levels were measured using liquid chromatography.	3 months
Secondary	Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.		3 months