Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00891917

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Down Syndrome	Dietary Supplement: Ubiquinol-10 Syrup Dietary Supplement: syrup (placebo)	Phase 2

Detailed Description

This is a randomized, double-blind, placebo-controlled clinical study of CoQ efficacy in a crossover design. Patients will be screened, enrolled, and studied in the outpatient clinic of the Thomas Center for Down Syndrome at CCHMC. All patients will be randomly assigned to either a liquid product (LiQ-NOL®) and an identical placebo liquid. Study drug and placebo will be administered twice a day (morning and evening).

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of Coenzyme q10 (Liq-nol®) Efficacy in Pediatric Patients With Down Syndrome

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Syrup identical placebo formulation to be administered twice a day.	Dietary Supplement: syrup (placebo) syrup looks exactly like the Ubiquinol-10 Syrup but has no active ingredients or supplementation
Active Comparator: Ubiquinol-10 Syrup CoQ (LiQ-NOL®) 10.0 mg/kg/d to be administered twice a day	Dietary Supplement: Ubiquinol-10 Syrup 10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months Other Names: LiQ-NOL

Arm

Intervention/Treatment

Placebo Comparator: Syrup

identical placebo formulation to be administered twice a day.

Dietary Supplement: syrup (placebo)

syrup looks exactly like the Ubiquinol-10 Syrup but has no active ingredients or supplementation

Active Comparator: Ubiquinol-10 Syrup

CoQ (LiQ-NOL®) 10.0 mg/kg/d to be administered twice a day

Dietary Supplement: Ubiquinol-10 Syrup

10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months

Other Names:

LiQ-NOL

Outcome Measures

Primary Outcome Measures

To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation. [beginning and end of 3 month treatment period]

Secondary Outcome Measures

To evaluate the effects of LiQ-NOL on child behavior. [beginning and end of 3 month treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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