Chronic Kidney DiseaseNCT01026363
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
A study testing Ergocalciferol and Calcitriol in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Vitamin D Deficiency
- What is being tested?
- Ergocalciferol and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)
Who cannot join
- 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
- use of active vitamin D analog within 30 days
- functioning renal transplant
- Symptoms of active infection
- Granulomatous disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Being tested
- Ergocalciferol, Calcitriol
- Keywords
- Vitamin D, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Vitamin D
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
CalcitriolDrug
Also called vitamin d
0.25 mcg tablet once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| ergocalciferol | Experimental | Ergocalciferol intervention arm Receives: Drug: Ergocalciferol |
| calcitriol | Experimental | calcitriol intervention arm Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
hCAP18 levels
Measured: 2 weeks
Secondary outcomes (6)
1,25-dihydroxyvitamin D
Measured: 2 weeks
25-hydroxyvitamin D
Measured: 2 weeks
calcium
Measured: 2 weeks
phosphorus
Measured: 2 weeks
Parathyroid hormone
Measured: 2 weeks
T-cell subsets
Measures of different types of T-cells
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2014
- Study completionDec 2014
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation, United States
- Responsible party
- Principal investigator, Ishir Bhan, MD, MPH, Massachusetts General Hospital
- Investigators
- Ishir Bhan, MD MPH, Principal investigator, Massachusetts General Hospital, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026363
- Sponsor's protocol ID
- 2009-P-001050/1
- Other IDs
- 1K23DK081677
- Status last verified
- Sep 2015
- First submitted
- 2 Dec 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CA Jr, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009 Feb 15;48(4):418-24. doi: 10.1086/596314.
PubMed 19133797
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01026363
- Acronym / sponsor ID
- 2009-P-001050/1
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Keywords
- Vitamin D, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation, United States
- Study start
- Dec 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2009 (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.
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ergocalciferol | Experimental | Drug: ErgocalciferolErgocalciferol intervention arm |
| calcitriol | Experimental | Drug: Calcitriolcalcitriol intervention arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)
Key exclusion criteria (5 listed)
- 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
- use of active vitamin D analog within 30 days
- functioning renal transplant
- Symptoms of active infection
- Granulomatous disorders
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 |
|---|---|---|
| ErgocalciferolAlso: Vitamin DErgocalciferol 50,000 IU capsule, one dose every other day x 5 doses | Drug | ergocalciferol |
| CalcitriolAlso: vitamin d0.25 mcg tablet once daily for 14 days | Drug | calcitriol |
Primary outcome
hCAP18 levels
Time frame: 2 weeks
6 secondary outcomes
1,25-dihydroxyvitamin D
Time frame: 2 weeks
25-hydroxyvitamin D
Time frame: 2 weeks
calcium
Time frame: 2 weeks
phosphorus
Time frame: 2 weeks
Parathyroid hormone
Time frame: 2 weeks
T-cell subsets
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Background: PubMed 19133797Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CA Jr, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009 Feb 15;48(4):418-24. doi: 10.1086/596314.
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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.
Ishir Bhan, MD MPH principal investigator
Massachusetts General Hospital, Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol and Calcitriol in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Massachusetts General Hospital at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
hCAP18 levels (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01026363, which also lists 1 linked publication.
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 23 Sep 2015.