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Trial record 15 of 607 for:    "lipid metabolism, inborn errors" OR "farber lipogranulomatosis"

Effects of Fish Oil and Colesevelam

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ClinicalTrials.gov Identifier: NCT01948648
Recruitment Status : Recruiting
First Posted : September 23, 2013
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

September 6, 2013
September 23, 2013
November 7, 2018
February 6, 2018
March 1, 2019   (Final data collection date for primary outcome measure)
Plasma plant sterol level [ Time Frame: 32 weeks ]
plasma plant sterol assessment using Gas Chromatography(GC)
Plasma plant sterol level [ Time Frame: 16 weeks ]
plasma plant sterol assessment using Gas Chromatography(GC)
Complete list of historical versions of study NCT01948648 on ClinicalTrials.gov Archive Site
  • Fatty acid [ Time Frame: 32 weeks ]
    use of gas chromatography technique to measure fish oil intervention
  • endothelial functions [ Time Frame: 32 weeks ]
    use of EndoPAT 2000 system to assess endothelial function
  • Cholesterol absorption [ Time Frame: 16 weeks ]
    use of stable isotope technique to assess cholesterol absorption
  • cholesterol synthesis [ Time Frame: 16 weeks ]
    use of stable isotope to assess cholesterol synthesis
Not Provided
Not Provided
 
Effects of Fish Oil and Colesevelam
Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Sitosterolemia
  • 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.
    Other Name: Lodalis
  • Dietary Supplement: Fish Oil
    In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.
    Other Name: Omega-3
  • 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.
    Other Name: Omega-3 and Lodalis
  • Active Comparator: Colesevelam
    3.75g/day for 6 weeks
    Intervention: Drug: Colesevelam
  • Active Comparator: Fish Oil
    1g/day for 6 weeks
    Intervention: Dietary Supplement: Fish Oil
  • Active Comparator: Combination of Fish Oil and Colesevelam
    3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks
    Intervention: Drug: Combination of fish oil and colesevelam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
15
December 31, 2019
March 1, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years and older   (Child, Adult, Older Adult)
No
Canada
 
 
NCT01948648
B2013:075
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP