Chronic Kidney DiseaseEarly Phase 1NCT00772772
Vitamin D Repletion in Chronic Kidney Disease
A Early Phase 1 study testing Vitamin D3 in people with Chronic Kidney Disease, run by Rockefeller University at 1 site in United States.
Trial summary
The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2009
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and post-menopausal females, between the age of 50 -80.
- Vitamin D 25-OH level less than 20 ng/ml
- Inclusion Criteria for Medium-level Kidney Function volunteers
- Males and post-menopausal females, between the age of 50 -80.
- Chronic kidney disease stage 3
- Vitamin D 25-OH level less than 20 ng/ml
Who cannot join
- Serum calcium level >10.5 mg/dl
- Serum phosphorus level > 5.5 mg/dl
- Serum PTH level < 35 pg/ml
- Active infection including HIV, Hepatitis B or C
- History of recent acute infection ( within 1 month)
- Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
Show all 15Show fewer
- Hgb< 10 g/dL
- Current use of Coumadin
- Current use of Vitamin D >400 IU/day
- Current use of systemic steroids or other immunosuppressants
- History of malignancy not in remission (>6 months)
- History of current ethanol abuse or illicit drug use
- History of significant emotional disorder within the past 5 years
- Participation in an investigational drug study within one month of screening
- Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3
The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease.
We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.
Read the detailed description
Your participation in this study requires:
- 4 visits to the outpatient clinic (including 1 screening visit)
- Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit
- Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.
- Conditions
- Chronic Kidney Disease
- Being tested
- Vitamin D3
- Keywords
- Vitamin D3 repletion, levels of endotoxin, intestinal permeability, accelerated atherosclerosis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin D
2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3 30,000 international units orally per week for 8 weeks Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endotoxin Activity
Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).
Measured: baseline and 8 weeks
Secondary outcomes (5)
Blood Pressure
Measured: after 8 weeks of vitamin D therapy
Intestinal Permeability
Measured: after 8 weeks of vitamin D therapy
Nuclear Magnetic Resonance (NMR) Lipoprotein Profile
Measured: after 8 weeks of vitamin D therapy
25-hydroxy Vitamin D (25-OH Vitamin D)
25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.
Measured: after 8 weeks of vitamin D therapy
1, 25-OH Vitamin D
Measured: after 8 weeks of vitamin D therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Ponda, Rockefeller University
- Investigators
- Manish Ponda, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772772
- Sponsor's protocol ID
- MAP-0626
- Status last verified
- Jan 2015
- First submitted
- 13 Oct 2008
- Last updated
- 15 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3
- ClinicalTrials.gov ID
- NCT00772772
- Acronym / sponsor ID
- MAP-0626
- Conditions
- Chronic Kidney Disease
- Keywords
- Vitamin D3 repletion, levels of endotoxin, intestinal permeability, accelerated atherosclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 13 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease.
We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.
Detailed description
Your participation in this study requires:
- 4 visits to the outpatient clinic (including 1 screening visit)
- Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit
- Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3Vitamin D3 30,000 international units orally per week for 8 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and post-menopausal females, between the age of 50 -80.
- Vitamin D 25-OH level less than 20 ng/ml
- Inclusion Criteria for Medium-level Kidney Function volunteers
- Males and post-menopausal females, between the age of 50 -80.
- Chronic kidney disease stage 3
Key exclusion criteria (15 listed)
- Serum calcium level >10.5 mg/dl
- Serum phosphorus level > 5.5 mg/dl
- Serum PTH level < 35 pg/ml
- Active infection including HIV, Hepatitis B or C
- History of recent acute infection ( within 1 month)
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 |
|---|---|---|
| Vitamin D3Also: Vitamin D2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly) | Drug | Vitamin D3 |
Primary outcome
Change in Endotoxin Activity
Time frame: baseline and 8 weeks
Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).
5 secondary outcomes
Blood Pressure
Time frame: after 8 weeks of vitamin D therapy
Intestinal Permeability
Time frame: after 8 weeks of vitamin D therapy
Nuclear Magnetic Resonance (NMR) Lipoprotein Profile
Time frame: after 8 weeks of vitamin D therapy
25-hydroxy Vitamin D (25-OH Vitamin D)
Time frame: after 8 weeks of vitamin D therapy
1, 25-OH Vitamin D
Time frame: after 8 weeks of vitamin D therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manish Ponda, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D3 in people with Chronic Kidney Disease, run by Rockefeller University 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 6 inclusion and 15 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 15 Jan 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endotoxin Activity (time frame: baseline and 8 weeks). 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 15 Jan 2015.