NCT01948648

Brief 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 sitosterolemia patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
4.4 years until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 10, 2020

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

September 6, 2013

Last Update Submit

November 6, 2020

Conditions

Sitosterolemia

Keywords

plant sterolscholesterolcolesevelamphytosterolemiafish oil

Outcome Measures

Primary Outcomes (1)

  • Plasma plant sterol level

    plasma plant sterol assessment using Gas Chromatography(GC)

    32 weeks

Secondary Outcomes (2)

  • Fatty acid

    32 weeks

  • endothelial functions

    32 weeks

Study Arms (3)

Colesevelam

ACTIVE COMPARATOR

3.75g/day for 6 weeks

Drug: Colesevelam

Fish Oil

ACTIVE COMPARATOR

1g/day for 6 weeks

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

Drug: Combination of fish oil and colesevelam

Interventions

ColesevelamDRUG

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.

Also known as: Lodalis
Colesevelam
Fish OilDIETARY_SUPPLEMENT

In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.

Also known as: Omega-3
Fish Oil
Combination of fish oil and colesevelamDRUG

combination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session.

Also known as: Omega-3 and Lodalis
Combination of Fish Oil and Colesevelam

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Intellectual disability
  • Bowel or biliary obstruction
  • Known hypersensitivity to colesevelam or any ingredients of colesevelam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Center for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Sitosterolemia

Interventions

Colesevelam HydrochlorideFish OilsDocosahexaenoic Acids

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOilsLipidsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsFatty Acids, UnsaturatedFatty Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 23, 2013

Study Start

February 6, 2018

Primary Completion

April 30, 2021

Study Completion

July 30, 2021

Last Updated

November 10, 2020

Record last verified: 2019-12

Locations

CA(1)