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Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

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ClinicalTrials.gov Identifier: NCT00891917
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Michael V. Miles, Children's Hospital Medical Center, Cincinnati

April 29, 2009
May 1, 2009
January 29, 2014
January 2005
November 2012   (Final data collection date for primary outcome measure)
To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation. [ Time Frame: beginning and end of 3 month treatment period ]
Same as current
Complete list of historical versions of study NCT00891917 on ClinicalTrials.gov Archive Site
To evaluate the effects of LiQ-NOL on child behavior. [ Time Frame: beginning and end of 3 month treatment period ]
Same as current
Not Provided
Not Provided
 
Liq-NOL Efficacy in Pediatric Patients With Down Syndrome
Evaluation of Coenzyme q10 (Liq-nol®) Efficacy in Pediatric Patients With Down Syndrome
The purpose of this study is to measure the effects of LiQ-NOL supplementation on language production using the Clinical Evaluation of Language Fundamentals test, language sampling using the mean length of utterance test, and speech articulation using the Goldman-Fristoe Test of Articulation.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Down Syndrome
Drug: Ubiquinol-10 Syrup
10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months
Other Name: LiQ-NOL
  • Placebo Comparator: Syrup
    Intervention: Drug: Ubiquinol-10 Syrup
  • Active Comparator: Ubiquinol-10 Syrup
    Intervention: Drug: Ubiquinol-10 Syrup

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
36
December 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients ranging from 6.0 years to 16 years of age.
  • Patients will have proven Trisomy 21.
  • Females, incapable of bearing children or capable of practicing adequate birth control methods. Abstinence will be acceptable.
  • Written informed consent will be obtained from parents of all subjects prior to enrollment. Verbal assent will be obtained from all patients with DS who have sufficient decision making ability and are at least 11 years old.

Exclusion Criteria:

  • Patients who have insufficient mental and/or motor capacity to complete testing measures.
  • Patients less than 6 years or older than 16 years of age.
  • Patients receiving CoQ supplementation within one month prior to the study.
  • Patients with evidence of disease which may adversely affect CoQ absorption, e.g. chronic diarrhea or inflammatory bowel disease.
  • Patients participating in other research studies or having exposure to investigational drugs within one month prior to this study.
  • Females, capable of bearing children, who are unsure of their pregnancy status or not practicing adequate birth control methods.
  • Females who are pregnant.
  • Patients with a known allergy to CoQ.
  • Patients receiving drug treatment which is know to affect CoQ, e.g. cholesterol-lowering drugs such as "statins".
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00891917
04-12-4
Yes
Not Provided
Not Provided
Dr. Michael V. Miles, Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Michael V Miles, Pharm.D. Childrens Hospital Medical Center, Cincinnati
Principal Investigator: Francis Hickey, M.D. Childrens Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
January 2014

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