SitosterolemiaNCT01948648
Effects of Fish Oil and Colesevelam (STAIR7007)
A study testing Colesevelam, Fish Oil and Combination of fish oil and colesevelam in people with Sitosterolemia, run by University of Manitoba at 1 site in Canada.
Trial summary
If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sitosterolemia
- What is being tested?
- Colesevelam, Fish Oil and Combination of fish oil and colesevelam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2018to 30 Jul 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
- Receiving ezetimibe treatment
- Over 8 years of age (no maximum)
- Concomitant illnesses or conditions
Who cannot join
- Pregnancy
- Intellectual disability
- Bowel or biliary obstruction
- Known hypersensitivity to colesevelam or any ingredients of colesevelam
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Center for Functional Foods and Nutraceuticals
Winnipeg, Manitoba
About this study
Official title: Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.
Read the detailed description
Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients.
The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.
- Conditions
- Sitosterolemia
- Being tested
- Colesevelam, Fish Oil, Combination of fish oil and colesevelam
- Keywords
- plant sterols, cholesterol, colesevelam, phytosterolemia, fish oil
- Medical subject headings
- Sitosterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColesevelamDrug
Also called Lodalis
Drug is in powder form, each packet contains 3.75g of colesevelam hydrochloride. Participant will mixed it with water and have 1 packet per day during the treatment session.
Fish OilDietary supplement
Also called Omega-3
In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.
Combination of fish oil and colesevelamDrug
Also called Omega-3 and Lodalis
combination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Colesevelam | Active comparator | 3.75g/day for 6 weeks Receives: Drug: Colesevelam |
| Fish Oil | Active comparator | 1g/day for 6 weeks Receives: Dietary Supplement: Fish Oil |
| Combination of Fish Oil and Colesevelam | Active comparator | 3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks Receives: Drug: Combination of fish oil and colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma plant sterol level
plasma plant sterol assessment using Gas Chromatography(GC)
Measured: 32 weeks
Secondary outcomes (2)
Fatty acid
use of gas chromatography technique to measure fish oil intervention
Measured: 32 weeks
endothelial functions
use of EndoPAT 2000 system to assess endothelial function
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study start6 Feb 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SitosterolemiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948648
- Sponsor's protocol ID
- B2013:075
- Status last verified
- Dec 2019
- First submitted
- 6 Sep 2013
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
- ClinicalTrials.gov ID
- NCT01948648
- Acronym / sponsor ID
- B2013:075
- Conditions
- Sitosterolemia
- Keywords
- plant sterols, cholesterol, colesevelam, phytosterolemia, fish oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 23 Sep 2013 (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.
If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.
Detailed description
Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients.
The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colesevelam | Active comparator | Drug: Colesevelam3.75g/day for 6 weeks |
| Fish Oil | Active comparator | Dietary Supplement: Fish Oil1g/day for 6 weeks |
| Combination of Fish Oil and Colesevelam | Active comparator | Drug: Combination of fish oil and colesevelam3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
- Receiving ezetimibe treatment
- Over 8 years of age (no maximum)
- Concomitant illnesses or conditions
Key exclusion criteria (4 listed)
- Pregnancy
- Intellectual disability
- Bowel or biliary obstruction
- Known hypersensitivity to colesevelam or any ingredients of colesevelam
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 |
|---|---|---|
| ColesevelamAlso: LodalisDrug is in powder form, each packet contains 3.75g of colesevelam hydrochloride. Participant will mixed it with water and have 1 packet per day during the treatment session. | Drug | Colesevelam |
| Fish OilAlso: Omega-3In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session. | Dietary supplement | Fish Oil |
| Combination of fish oil and colesevelamAlso: Omega-3 and Lodaliscombination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session. | Drug | Combination of Fish Oil and Colesevelam |
Primary outcome
Plasma plant sterol level
Time frame: 32 weeks
plasma plant sterol assessment using Gas Chromatography(GC)
2 secondary outcomes
Fatty acid
Time frame: 32 weeks
endothelial functions
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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 study testing Colesevelam, Fish Oil and Combination of fish oil and colesevelam in people with Sitosterolemia, run by University of Manitoba at 1 site in Canada.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. 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 Canada. 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. 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?
Results are not available in the source record.
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?
Plasma plant sterol level (time frame: 32 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 10 Nov 2020.