Chronic Kidney DiseasePhase 4NCT01675557
Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis
A Phase 4 study testing Vitamin D3 and Vitamin D2 in people with Chronic Kidney Disease, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Vitamin D3 and Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis
Who cannot join
- They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake >1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney
The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.
Read the detailed description
This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).
- Conditions
- Chronic Kidney Disease
- Being tested
- Vitamin D3, Vitamin D2, Placebo
- Keywords
- chronic kidney disease
- 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 D3Dietary supplement
Also called Cholecalciferol
a single oral dose of vitamin D3
Vitamin D2Dietary supplement
Also called ergocalciferol
a single oral dose of vitamin D2
PlaceboDietary supplement
a single oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 | Active comparator | a single oral dose of vitamin D2 Receives: Dietary Supplement: Vitamin D2 |
| Placebo | Placebo comparator | a single oral dose of a placebo Receives: Dietary Supplement: Placebo |
| Vitamin D3 | Experimental | A single oral dose of vitamin D3 Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D
25(OH)D levels will be drawn at intervals over 16 weeks.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura AG Armas, MD,MS, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675557
- Sponsor's protocol ID
- Creighton15
- Status last verified
- Feb 2015
- First submitted
- 28 Aug 2012
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.
PubMed 28506446
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney
- ClinicalTrials.gov ID
- NCT01675557
- Acronym / sponsor ID
- Creighton15
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Aug 2012 (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 purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.
Detailed description
This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 | Active comparator | Dietary Supplement: Vitamin D2a single oral dose of vitamin D2 |
| Placebo | Placebo comparator | Dietary Supplement: Placeboa single oral dose of a placebo |
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3A single oral dose of vitamin D3 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis
Key exclusion criteria (1 listed)
- They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake >1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.
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: Cholecalciferola single oral dose of vitamin D3 | Dietary supplement | Vitamin D3 |
| Vitamin D2Also: ergocalciferola single oral dose of vitamin D2 | Dietary supplement | Vitamin D2 |
| Placeboa single oral dose of placebo | Dietary supplement | Placebo |
Primary outcome
25(OH)D
Time frame: 16 weeks
25(OH)D levels will be drawn at intervals over 16 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 26 Feb 2015.
- Derived from this study: PubMed 28506446Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.
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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 AG Armas, MD,MS principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 and Vitamin D2 in people with Chronic Kidney Disease, run by Creighton 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 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: finished, as of the sponsor's last update on 26 Feb 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
25(OH)D (time frame: 16 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 NCT01675557, 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 26 Feb 2015.