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Effects of Fish Oil and Colesevelam (STAIR7007)

NCT01948648 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-11-10

No results posted yet for this study

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.

Conditions

  • Sitosterolemia

Interventions

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.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2021-04-30
Completion
2021-07-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948648 on ClinicalTrials.gov