Effects of Fish Oil and Colesevelam (STAIR7007)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01948648
• Date of registration: 06/09/2013
• Prospective Registration: Yes
• Primary sponsor: University of Manitoba
• Public title: Effects of Fish Oil and Colesevelam (STAIR7007)
• Scientific title: Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
• Date of first enrolment: February 6, 2018
• Target sample size: 13
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01948648
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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



Age minimum: 8 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sitosterolemia

Intervention(s)

Drug: Colesevelam

Dietary Supplement: Fish Oil

Drug: Combination of fish oil and colesevelam

Primary Outcome(s)

Plasma plant sterol level [Time Frame: 32 weeks]

Secondary Outcome(s)

Fatty acid [Time Frame: 32 weeks]

endothelial functions [Time Frame: 32 weeks]

Secondary ID(s)

B2013:075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors