NCT00891917

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 9, 2020

Status Verified

January 1, 2014

Enrollment Period

7.8 years

First QC Date

April 29, 2009

Last Update Submit

September 4, 2020

Conditions

Down Syndrome

Keywords

Down syndromecoenzyme Q10language functionbehavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the effects of LiQ-NOL on child behavior.

    beginning and end of 3 month treatment period

Study Arms (2)

Syrup

PLACEBO COMPARATOR

identical placebo formulation to be administered twice a day.

Dietary Supplement: syrup (placebo)

Ubiquinol-10 Syrup

ACTIVE COMPARATOR

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

Dietary Supplement: Ubiquinol-10 Syrup

Interventions

Ubiquinol-10 SyrupDIETARY_SUPPLEMENT

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

Also known as: LiQ-NOL
Ubiquinol-10 Syrup
syrup (placebo)DIETARY_SUPPLEMENT

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

Syrup

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related 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. doi: 10.1016/j.pediatrneurol.2007.08.003.

    PMID: 18021919BACKGROUND

  • 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. doi: 10.1016/j.pediatrneurol.2005.11.004.

    PMID: 16814082BACKGROUND

MeSH Terms

Conditions

Down SyndromeLanguageBehavior

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornCommunication

Study Officials

  • Michael V Miles, Pharm.D.

    Childrens Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Francis Hickey, M.D.

    Childrens Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

January 1, 2005

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

September 9, 2020

Record last verified: 2014-01

Locations

US(1)