Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Michael V. Miles, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00891917
First received: April 29, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Down Syndrome
Drug: Ubiquinol-10 Syrup
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Coenzyme q10 (Liq-nol®) Efficacy in Pediatric Patients With Down Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of LiQ-NOL on child behavior. [ Time Frame: beginning and end of 3 month treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Syrup 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
Active Comparator: Ubiquinol-10 Syrup 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

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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".
  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: NCT00891917

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Michael V Miles, Pharm.D. Childrens Hospital Medical Center, Cincinnati
Principal Investigator: Francis Hickey, M.D. Childrens Hospital Medical Center, Cincinnati
  More Information

Publications:
Responsible Party: Dr. Michael V. Miles, Prof. of Clin. Peds., Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00891917     History of Changes
Other Study ID Numbers: 04-12-4
Study First Received: April 29, 2009
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Down syndrome
coenzyme Q10
language function
behavior

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Disease
Pathologic Processes
Coenzyme Q10
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014