Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Syrup

identical placebo formulation to be administered twice a day.

Group Type PLACEBO_COMPARATOR

syrup (placebo)

Intervention Type DIETARY_SUPPLEMENT

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

Ubiquinol-10 Syrup

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

Group Type ACTIVE_COMPARATOR

Ubiquinol-10 Syrup

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ubiquinol-10 Syrup

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

Intervention Type DIETARY_SUPPLEMENT

syrup (placebo)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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LiQ-NOL

Eligibility Criteria

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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".

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No