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

NCT ID: NCT01029002

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Chronic Renal Insufficiency; Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D 50000 IU

Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Placebo

Patients randomized to this arm will receive a placebo pill once weekly.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients randomized to this arm will receive one placebo pill once weekly.

Interventions

Vitamin D

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

Intervention Type: DRUG

Placebo

Patients randomized to this arm will receive one placebo pill once weekly.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michal Melamed, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore medical center

The Bronx, New York, United States

Countries

United States

Other Identifiers

K23DK078774

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007-266

Identifier Type: -

Identifier Source: org_study_id