NCT01007344|CompletedPhase 3
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia
A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
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A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
Sponsor study identifier
interventional
30
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2009
Actual (reported)November 4, 2009
Actual (reported)December 2010
Actual (reported)December 2010
Actual (reported)fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein
4 weeks
LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione
4 weeks
complete blood count
4 weeks
2 muffins and 1 slice of bread for a total of 30g flaxseed per day
2 muffins and 1 slice of bread containing whole wheat flour per day
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Wong H, Chahal N, Manlhiot C, Niedra E, McCrindle BW. Flaxseed in pediatric hyperlipidemia: a placebo-controlled, blinded, randomized clinical trial of dietary flaxseed supplementation for children and adolescents with hypercholesterolemia. JAMA Pediatr. 2013 Aug 1;167(8):708-13. doi: 10.1001/jamapediatrics.2013.1442.
Brian McCrindle, MD
The Hospital for Sick Children
30 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2009
First Posted
November 4, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
August 27, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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