Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

Cincinnati Children's Hospital Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Down Syndrome

Treatments

Dietary Supplement: Ubiquinol-10 Syrup

Dietary Supplement: syrup (placebo)

Study type

Interventional

Funder types

Other

Identifiers

NCT00891917

2008-0489

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

6 to 16 years old

Volunteers

No 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".