Trial record 3 of 13 for:    "sitosterolemia" OR "beta-sitosterolemia" OR "phytosterolaemia" OR "sitosterolaemia" OR "Mediterranean stomatocytosis macrothrombocytopenia"

Effects of Colesevelam

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01948648
First received: September 6, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

If treatment of colesevelam in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatment with colesevelam decrease cholesterol absorption and increase cholesterol fractional synthesis in sitosterolemia patients. This hypothesis will be examined by measuring changes in cholesterol absorption and synthesis using isotope technique.


Condition Intervention
Sitosterolemia
Drug: Colesevelam
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Colesevelam as an Adjunct Therapy for Sitosterolemia

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Plasma plant sterol level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    plasma plant sterol assessment using Gas Chromatography(GC)


Secondary Outcome Measures:
  • Cholesterol absorption [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    use of stable isotope technique to assess cholesterol absorption

  • cholesterol synthesis [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    use of stable isotope to assess cholesterol synthesis


Estimated Enrollment: 15
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Colesevelam
3.75mg/day for 6 weeks
Drug: Colesevelam
Other Name: Lodalis
Placebo Comparator: Placebo
3.75 mg/day for 6 weeks
Other: Placebo
placebo
Other Name: Sugar Pill

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948648

Locations
Canada, Manitoba
Richardson Center for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01948648     History of Changes
Other Study ID Numbers: B2013:075
Study First Received: September 6, 2013
Last Updated: September 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
plant sterols
cholesterol
colesevelam
phytosterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Intestinal Diseases
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Colesevelam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014