Chronic Kidney DiseasesNCT04167111
Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
A study testing Cholecalciferol in people with Chronic Kidney Diseases, run by University of Nebraska.
Trial summary
Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2021to 6 May 2021
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist.
Who cannot join
- on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.
About this study
Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients
Read the detailed description
Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Cholecalciferol
- 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.
CholecalciferolDietary supplement
Also called Vitamin D3
Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 4000 | Active comparator | At baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day. Receives: Dietary Supplement: Cholecalciferol |
| Vitamin D 2400 | Active comparator | At baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day. Receives: Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D level
25(OH)D level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start6 May 2021
- Primary completion6 May 2021
- Study completion6 May 2021
Why it stopped: Covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be started on Vitamin D3 4000 per day or 2400 IU per day at baseline and based on 3 month 25(OH)D levels, will be adjusted to a different vitamin D dose if needed
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Graeff-Armas, MD, MS, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167111
- Sponsor's protocol ID
- 0646-19-FB
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2019
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT04167111
- Acronym / sponsor ID
- 0646-19-FB
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 18 Nov 2019 (actual)
- 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.
Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients
Detailed description
Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be started on Vitamin D3 4000 per day or 2400 IU per day at baseline and based on 3 month 25(OH)D levels, will be adjusted to a different vitamin D dose if needed
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 4000 | Active comparator | Dietary Supplement: CholecalciferolAt baseline, if subjects 25(OH)D levels are 12-19.9, they will be started on 4000 IU per day. |
| Vitamin D 2400 | Active comparator | Dietary Supplement: CholecalciferolAt baseline, if subjects 25(OH)D levels are 20-30, they will be started on 2400 IU per day. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- likely be able to complete the study, >3 months on hemodialysis, receiving standard of care through their nephrologist.
Key exclusion criteria (1 listed)
- on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D >800 IU per day, 25(OH)D level >30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3Vitamin D | Dietary supplement | Vitamin D 2400, Vitamin D 4000 |
Primary outcome
25(OH)D level
Time frame: 6 months
25(OH)D level
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Laura Graeff-Armas, MD, MS, PhD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Chronic Kidney Diseases, run by University of Nebraska.
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 1 inclusion and 1 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
25(OH)D level (time frame: 6 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 3 Sep 2024.