Effects of Fish Oil and Colesevelam (STAIR7007)

Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01948648

Enrollment

Registered

2013-09-23

Start date

2018-02-06

Completion date

2021-07-30

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sitosterolemia

Keywords

plant sterols, cholesterol, colesevelam, phytosterolemia, fish oil

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.

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.

Interventions

DRUGColesevelam

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.

DIETARY_SUPPLEMENTFish Oil

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

DRUGCombination of fish oil and colesevelam

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters 2. Receiving ezetimibe treatment 3. Over 8 years of age (no maximum) 4. Concomitant illnesses or conditions

Exclusion criteria

1. Pregnancy 2. Intellectual disability 3. Bowel or biliary obstruction 4. Known hypersensitivity to colesevelam or any ingredients of colesevelam

Design outcomes

Primary

Measure	Time frame	Description
Plasma plant sterol level	32 weeks	plasma plant sterol assessment using Gas Chromatography(GC)

Secondary

Measure	Time frame	Description
Fatty acid	32 weeks	use of gas chromatography technique to measure fish oil intervention
endothelial functions	32 weeks	use of EndoPAT 2000 system to assess endothelial function

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026