NCT01835639

Brief Summary

This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

4.4 years

First QC Date

April 17, 2013

Last Update Submit

August 9, 2019

Conditions

Glomerular Disease

Keywords

Glomerular DiseaseVitamin DSteroid-resistant nephrotic syndromeMinimal change diseaseFocal segmental glomerulosclerosis (FSGS)Membranous NephropathyMembranoprolfierative Glomerulonephritisimmunoglobulin A (IgA) NephropathyFSGSIgA Nephropathy

Outcome Measures

Primary Outcomes (2)

  • To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.

    12 weeks

  • To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.

    12 weeks

Secondary Outcomes (3)

  • To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.

    12 weeks

  • To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).

    12 weeks

  • To assess arterial stiffness, measured by changes in pulse wave velocity.

    12 weeks

Study Arms (1)

Vitamin D Supplementation

EXPERIMENTAL

Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

Interventions

Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeksDIETARY_SUPPLEMENT

Supplements will be provided as oral capsules.

Also known as: Vitamin D
Vitamin D Supplementation

Eligibility Criteria

Age5 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males or females, age 5-30 years
  • Diagnosis of primary glomerular disease (such as steroid-resistant nephrotic syndrome, minimal change disease, FSGS, membranous nephropathy, membranoprolfierative glomerulonephritis, and Immunoglobulin A \[IgA\] nephropathy) without systemic inflammatory disorders (i.e. lupus, vasculitis)
  • Serum 25(OH)D level \<30 ng/ml and urine protein:creatinine ratio ≥0.5 at Screening Visit.

You may not qualify if:

  • Pregnancy
  • estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73m2 at Screening Visit
  • Serum phosphorus \> 5.5 mg/dl or hypercalcemia
  • Chronic medical conditions or medications unrelated to the renal disease that may impact vitamin D status
  • Known history of kidney stone(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Johns Hopkins University,Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

Location

North Shore-Long Island Jewish Health System

New Hyde Park, New York, 11040, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Nephrotic SyndromeNephrosis, LipoidGlomerulosclerosis, Focal SegmentalGlomerulonephritis, MembranousKidney DiseasesGlomerulonephritis, IGA

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

NephrosisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlomerulonephritisNephritisAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Michelle Denburg, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

US(5)