Hemodialysis PatientsPhase 4NCT01596842
Effect of Omega-3 Fatty Acid on Vitamin D Activation
A Phase 4 study testing Omega-3 fatty acid ethylester 90, Olive oil and cholecalciferol in people with Hemodialysis Patients and Vitamin D Insufficiency, run by Dong-A University at 1 site in South Korea.
Trial summary
Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency
- What is being tested?
- Omega-3 fatty acid ethylester 90, Olive oil and cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2012
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D < 30 ng/mL
Who cannot join
- Patients with a history of active infection within 3 months,
- Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
- Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
- Patients with a history of hospital admission within 3 months,
- Patients with a history of bleeding within 3 months,
- Patients with thrombocytopenia,
Show all 9Show fewer
- Patients with current use of warfarin,
- Patients with an albumin level < 3.0 g/dL,
- Patients with malignancy and/or liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.
- Being tested
- Omega-3 fatty acid ethylester 90, Olive oil, cholecalciferol
- Keywords
- Omega-3 fatty acid, vitamin D, ergocalciferol, hemodialysis
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid ethylester 90Drug
Also called Omacor®
Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
Olive oilOther
Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferolOther
if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid | Active comparator | Not described Receives: Drug: Omega-3 fatty acid ethylester 90; Other: cholecalciferol |
| Olive oil | Placebo comparator | Not described Receives: Other: Olive oil; Other: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D Levels at 12 Weeks
Measured: 12 weeks
Secondary outcomes (8)
Hemoglobin Levels at 12 Weeks
Measured: 12 weeks
Changes of Calcium Levels
Measured: 4 weeks, 8 weeks and 12 weeks
Change of Intact Parathyroid Hormone
Measured: 12 weeks
Change of Fetuin-A Levels
Measured: 12 weeks
Change of FGF-23 Levels
Measured: 12 weeks
Changes of Phosphorous Levels
Measured: 4 weeks, 8 weeks and 12 weeks
Changes of Erythropoietin Doses
Measured: 4 weeks, 8 weeks and 12 weeks
Changes of Phosphate Binder Doses
Measured: 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WON SUK AN, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596842
- Sponsor's protocol ID
- DAU-12-073
- Status last verified
- Mar 2015
- First submitted
- 8 May 2012
- Last updated
- 10 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.
PubMed 25636157
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01596842
- Acronym / sponsor ID
- DAU-12-073
- Keywords
- Omega-3 fatty acid, vitamin D, ergocalciferol, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 10 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid | Active comparator | Drug: Omega-3 fatty acid ethylester 90, Other: cholecalciferol |
| Olive oil | Placebo comparator | Other: Olive oil, Other: cholecalciferol |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D < 30 ng/mL
Key exclusion criteria (9 listed)
- Patients with a history of active infection within 3 months,
- Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
- Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
- Patients with a history of hospital admission within 3 months,
- Patients with a history of bleeding within 3 months,
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 |
|---|---|---|
| Omega-3 fatty acid ethylester 90Also: Omacor®Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks | Drug | Omega-3 fatty acid |
| Olive oilOlive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks | Other | Olive oil |
| cholecalciferolif baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks | Other | Olive oil, Omega-3 fatty acid |
Primary outcome
25-hydroxyvitamin D Levels at 12 Weeks
Time frame: 12 weeks
8 secondary outcomes
Hemoglobin Levels at 12 Weeks
Time frame: 12 weeks
Changes of Calcium Levels
Time frame: 4 weeks, 8 weeks and 12 weeks
Change of Intact Parathyroid Hormone
Time frame: 12 weeks
Change of Fetuin-A Levels
Time frame: 12 weeks
Change of FGF-23 Levels
Time frame: 12 weeks
Changes of Phosphorous Levels
Time frame: 4 weeks, 8 weeks and 12 weeks
Changes of Erythropoietin Doses
Time frame: 4 weeks, 8 weeks and 12 weeks
Changes of Phosphate Binder Doses
Time frame: 4 weeks, 8 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25636157Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.
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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 Omega-3 fatty acid ethylester 90, Olive oil and cholecalciferol in people with Hemodialysis Patients and Vitamin D Insufficiency, run by Dong-A University at 1 site in South Korea.
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 9 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 10 Mar 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2015). 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?
25-hydroxyvitamin D Levels at 12 Weeks (time frame: 12 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 NCT01596842, 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 10 Mar 2015.