CKDPhase 4NCT03073369
Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease
A Phase 4 study testing Ergocalciferol 50000 UNT in people with CKD and Chronic Kidney Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD). Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- CKD, Chronic Kidney Diseases, Hepcidin
- What is being tested?
- Ergocalciferol 50000 UNT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to Dec 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D < 30 ng/ml), and with absolute iron deficiency (TSAT < 20 and Ferritin <100) or iron restriction (TSAT < 20 and Ferritin > 100).
Who cannot join
- Active vitamin D analog therapy or history of recent (< 3 months) use.
- Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.
- Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.
- Oral iron therapy started within the last 3 months.
- Hb < 8.0 g/dL for males and Hb <7.0 g/dL for females.
- Pregnancy or lactation.
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- Serum calcium > 10.0 mg/dL or phosphorus > 4.5 mg/dL.
- Subjects with acute kidney injury or rapidly declining GFR.
- Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant.
- Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Targeting the Interactions Between Disordered Iron Homeostasis and Mineral Metabolism in Chronic Kidney Disease (Aim 1)
The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).
Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.
Read more
New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.
In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.
- Conditions
- CKD, Chronic Kidney Diseases, Hepcidin, Ergocalciferol, Vitamin D, Iron-deficiency
- Being tested
- Ergocalciferol 50000 UNT, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol 50000 UNTDrug
Oral Ergocalciferol 50000 IU once daily for 6 weeks
PlaceboDrug
Oral Placebo - one capsule once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral Ergocalciferol | Active comparator | Oral Ergocalciferol 50000 IU once daily for 6 weeks Receives: Drug: Ergocalciferol 50000 UNT |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum hepcidin levels
Difference in change in serum hepcidin levels (ng/ml) over time between the two groups
Measured: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Secondary outcomes (4)
Change in serum hemoglobin level
Difference in change in serum hemoglobin levels (g/dL) over time between the two groups
Measured: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in serum ferritin level
Difference in change in serum ferritin levels (ng/ml) over time between the two groups
Measured: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in percent transferrin saturation
Difference in change in percent transferrin saturation (%) over time between the two groups
Measured: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in serum iron level
Difference in change in serum iron levels (mcg/dL) over time between the two groups
Measured: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Jan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Study didn't materialize for various reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Bhupesh Panwar, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073369
- Sponsor's protocol ID
- F170216006
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Interactions Between Disordered Iron Homeostasis and Mineral Metabolism in Chronic Kidney Disease (Aim 1)
- ClinicalTrials.gov ID
- NCT03073369
- Acronym / sponsor ID
- F170216006
- Conditions
- CKD, Chronic Kidney Diseases, Hepcidin, Ergocalciferol, Vitamin D, Iron-deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study didn't materialize for various reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Mar 2017 (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.
The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).
Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.
New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.
In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.
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 |
|---|---|---|
| Oral Ergocalciferol | Active comparator | Drug: Ergocalciferol 50000 UNTOral Ergocalciferol 50000 IU once daily for 6 weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D < 30 ng/ml), and with absolute iron deficiency (TSAT < 20 and Ferritin <100) or iron restriction (TSAT < 20 and Ferritin > 100).
Key exclusion criteria (10 listed)
- Active vitamin D analog therapy or history of recent (< 3 months) use.
- Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.
- Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.
- Oral iron therapy started within the last 3 months.
- Hb < 8.0 g/dL for males and Hb <7.0 g/dL for females.
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 |
|---|---|---|
| Ergocalciferol 50000 UNTOral Ergocalciferol 50000 IU once daily for 6 weeks | Drug | Oral Ergocalciferol |
| PlaceboOral Placebo - one capsule once daily for 6 weeks | Drug | Placebo |
Primary outcome
Change in serum hepcidin levels
Time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Difference in change in serum hepcidin levels (ng/ml) over time between the two groups
4 secondary outcomes
Change in serum hemoglobin level
Time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in serum ferritin level
Time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in percent transferrin saturation
Time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Change in serum iron level
Time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 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 15 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ergocalciferol 50000 UNT in people with CKD and Chronic Kidney Diseases, run by University of Alabama at Birmingham 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 10 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 15 Mar 2018. 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 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?
Change in serum hepcidin levels (time frame: At Day 0, Day 3, 1 week, 4 weeks and 6 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 Mar 2018.