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Trial record 15 of 596 for:    "lipid metabolism, inborn errors" OR "farber lipogranulomatosis"

Effects of Fish Oil and Colesevelam

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ClinicalTrials.gov Identifier: NCT01948648
Recruitment Status : Unknown
Verified August 2016 by University of Manitoba.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2013
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

September 6, 2013
September 23, 2013
August 31, 2016
October 2016
December 2017   (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
    Other Name: Lodalis
  • Dietary Supplement: Fish Oil
    Other Name: Omega-3
  • Drug: Combination of fish oil and colesevelam
    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.
 
Unknown status
16
15
December 2017
December 2017   (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 12 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
12 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01948648
B2013:075
Yes
Not Provided
Not Provided
University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
August 2016

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