Chronic Renal InsufficiencyPhase 3NCT01029002
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
A Phase 3 study testing Vitamin D in people with Chronic Renal Insufficiency and Proteinuria, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Insufficiency, Proteinuria
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 25(OH) vitamin D level >12.5 and <75 nmol/L
Who cannot join
- On vitamin D in past 4 weeks
- Plans to relocate out of New York City in the next 6 months
- 25 (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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore medical center
The Bronx, New York, 10467
About this study
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.
Read the detailed description
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
- Conditions
- Chronic Renal Insufficiency, Proteinuria
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, CKD, proteinuria
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
PlaceboOther
Patients randomized to this arm will receive one placebo pill once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 50000 IU | Experimental | Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Patients randomized to this arm will receive a placebo pill once weekly. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
25(OH) vitamin D levels were measured using liquid chromatography.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2014
- Study completionJun 2014
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 Renal InsufficiencyStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Melamed, MD, MHS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029002
- Sponsor's protocol ID
- 2007-266
- Other IDs
- K23DK078774
- Status last verified
- Aug 2023
- First submitted
- 7 Dec 2009
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01029002
- Acronym / sponsor ID
- 2007-266
- Conditions
- Chronic Renal Insufficiency, Proteinuria
- Keywords
- Vitamin D, CKD, proteinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 50000 IU | Experimental | Drug: Vitamin DPatients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. |
| Placebo | Placebo comparator | Other: PlaceboPatients randomized to this arm will receive a placebo pill once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (12 listed)
- On vitamin D in past 4 weeks
- Plans to relocate out of New York City in the next 6 months
- 25 (OH) Vitamin D level <12.5 nmol/L
- HIV infection
- History of hypercalcemia or kidney stones
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 DVitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months | Drug | Vitamin D 50000 IU |
| PlaceboPatients randomized to this arm will receive one placebo pill once weekly. | Other | Placebo |
Primary outcome
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
Time frame: 3 months
Urine albumin and creatinine were measured on spot urine specimens.
2 secondary outcomes
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.
Time frame: 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.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- 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.
Michal Melamed, MD, MHS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Chronic Renal Insufficiency and Proteinuria, run by Albert Einstein College of Medicine 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 7 inclusion and 12 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 16 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Aug 2023). 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?
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. (time frame: 3 months). 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 16 Aug 2023.