Glomerular DiseaseNCT01835639
Vitamin D Supplementation in Glomerular Disease
A study testing Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks in people with Glomerular Disease, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial summary
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. . Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Glomerular Disease
- What is being tested?
- Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University,Division of Pediatric Nephrology
Baltimore, Maryland, 21287
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
Read the detailed description
Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic patients have very low vitamin D levels, and the underlying mechanisms are not known. Furthermore, approaches to safely and effectively supplement vitamin D in these patients have not been established. The purpose of this research study is to learn if vitamin D supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. About 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin D supplements each day for 12 weeks and will have 3 study visits.
- Conditions
- Glomerular Disease
- Being tested
- Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
- Keywords
- Glomerular Disease, Vitamin D, Steroid-resistant nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis (FSGS), Membranous Nephropathy, Membranoprolfierative Glomerulonephritis, immunoglobulin A (IgA) Nephropathy, FSGS, IgA Nephropathy
- Medical subject headings
- Nephrotic Syndrome, Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous, Kidney Diseases, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeksDietary supplement
Also called Vitamin D
Supplements will be provided as oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplementation | Experimental | Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks Receives: Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
Measured: 12 weeks
To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.
Measured: 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.
Measured: 12 weeks
To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).
Measured: 12 weeks
To assess arterial stiffness, measured by changes in pulse wave velocity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Society of Nephrology, The NephCure Foundation
- Responsible party
- Sponsor
- Investigators
- Michelle Denburg, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835639
- Sponsor's protocol ID
- 12-009753
- Other IDs
- K23DK093556
- Status last verified
- Aug 2019
- First submitted
- 17 Apr 2013
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
- ClinicalTrials.gov ID
- NCT01835639
- Acronym / sponsor ID
- 12-009753
- Conditions
- Glomerular Disease
- Keywords
- Glomerular Disease, Vitamin D, Steroid-resistant nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis (FSGS), Membranous Nephropathy, Membranoprolfierative Glomerulonephritis, immunoglobulin A (IgA) Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Society of Nephrology, The NephCure Foundation
- Study start
- Apr 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
Detailed description
Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic patients have very low vitamin D levels, and the underlying mechanisms are not known. Furthermore, approaches to safely and effectively supplement vitamin D in these patients have not been established. The purpose of this research study is to learn if vitamin D supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. About 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin D supplements each day for 12 weeks and will have 3 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplementation | Experimental | Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeksCholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeksAlso: Vitamin DSupplements will be provided as oral capsules. | Dietary supplement | Vitamin D Supplementation |
Primary outcome
To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
Time frame: 12 weeks
To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.
Time frame: 12 weeks
3 secondary outcomes
To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.
Time frame: 12 weeks
To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).
Time frame: 12 weeks
To assess arterial stiffness, measured by changes in pulse wave velocity.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Denburg, MD, MSCE principal investigator
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks in people with Glomerular Disease, run by Children's Hospital of Philadelphia at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.