Effects of Fish Oil and Colesevelam (STAIR7007)

Sitosterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01948648
• Other study ID #: B2013:075
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2019
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 sitosterolemia patients.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: July 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sitosterolemia

Intervention

Drug:
• Colesevelam
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 Supplement:
• Fish Oil
In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.

Drug:
• Combination 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.

Locations

Country	Name	City	State
Canada	Richardson Center for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma plant sterol level	plasma plant sterol assessment using Gas Chromatography(GC)	32 weeks
Secondary	Fatty acid	use of gas chromatography technique to measure fish oil intervention	32 weeks
Secondary	endothelial functions	use of EndoPAT 2000 system to assess endothelial function	32 weeks