Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00891917
• Other study ID #: 2008-0489
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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".

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Ubiquinol-10 Syrup
10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months
• syrup (placebo)
syrup looks exactly like the Ubiquinol-10 Syrup but has no active ingredients or supplementation

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (2)

Miles MV, Patterson BJ, Chalfonte-Evans ML, Horn PS, Hickey FJ, Schapiro MB, Steele PE, Tang PH, Hotze SL. Coenzyme Q10 (ubiquinol-10) supplementation improves oxidative imbalance in children with trisomy 21. Pediatr Neurol. 2007 Dec;37(6):398-403. — View Citation

Miles MV, Patterson BJ, Schapiro MB, Hickey FJ, Chalfonte-Evans M, Horn PS, Hotze SL. Coenzyme Q10 absorption and tolerance in children with Down syndrome: a dose-ranging trial. Pediatr Neurol. 2006 Jul;35(1):30-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the effects of LiQ-NOL on child behavior.		beginning and end of 3 month treatment period