NCT01029002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

August 16, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

4.7 years

First QC Date

December 7, 2009

Results QC Date

February 17, 2023

Last Update Submit

August 14, 2023

Conditions

Chronic Renal InsufficiencyProteinuria

Keywords

Vitamin DCKDproteinuria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

    3 months

  • 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

Study Arms (2)

Vitamin D 50000 IU

EXPERIMENTAL

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

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin DDRUG

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

Vitamin D 50000 IU
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • (OH) vitamin D level \>12.5 and \<75 nmol/L

You may not qualify if:

  • On vitamin D in past 4 weeks
  • Plans to relocate out of New York City in the next 6 months
  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore medical center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Michal Melamed
Organization
Albert Einstein College of Medicine
michal.melamed@einsteinmed.edu
718-430-2304

Study Officials

  • Michal Melamed, MD, MHS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 16, 2023

Results First Posted

August 16, 2023

Record last verified: 2023-08

Locations

US(1)