Down Syndrome
Conditions
Keywords
Down syndrome, coenzyme Q10, language function, behavior
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.
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).
Interventions
DIETARY_SUPPLEMENTUbiquinol-10 Syrup
10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months
DIETARY_SUPPLEMENTsyrup (placebo)
syrup looks exactly like the Ubiquinol-10 Syrup but has no active ingredients or supplementation
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the effects of LiQ-NOL on child behavior. | beginning and end of 3 month treatment period |
Countries
United States
Outcome results
None listed