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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01029002
First received: December 7, 2009
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Chronic Renal Insufficiency
Proteinuria
Drug: Vitamin D
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • To assess the effect of vitamin D supplementation on albuminuria in CKD patients as assessed by urine albumin/creatinine measures. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess whether 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess the effect of vitamin D supplementation on mean systolic blood pressure as measured by ambulatory blood pressure in CKD patients as a secondary outcome. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: October 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D 50000 IU
Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly.
Drug: Vitamin D
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
Placebo Comparator: Placebo
Patients randomized to this arm will receive a placebo pill once weekly.
Other: Placebo
Patients randomized to this arm will receive one placebo pill once weekly.

Detailed Description:

This RCT will enroll 128 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029002

Contacts
Contact: Michal Melamed, MD, MHS 718-430-2304 mmelamed@aecom.yu.edu
Contact: Kristen Meier, BS, MS 718-430-3301 meier.kristen@gmail.com

Locations
United States, New York
Montefiore medical center Recruiting
Bronx, New York, United States, 10467
Contact: Michal Melamed, MD, MHS    718-430-2304    mmelamed@aecom.yu.edu   
Contact: Kristen Meier, BS, MS    718-430-3301    meier.kristen@gmail.com   
Principal Investigator: Michal Melamed, MD, MHS         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Michal Melamed, MD, MHS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01029002     History of Changes
Other Study ID Numbers: 2007-266, NIH grant K23 DK078774
Study First Received: December 7, 2009
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Vitamin D
CKD
proteinuria

Additional relevant MeSH terms:
Urination Disorders
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Proteinuria
Renal Insufficiency
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014