Dettagli per singolo studio

DEC-NET Serial number IT453

Published online	02/08/2005 17.04.00
Last updated	23/12/2005 15.04.38

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	DOWN
Experimental drug
UBIDECARENONE Treatment regimen (dosage and duration)
Gender	Both
Age (range)	4-12 years
Eligibility criteria


Exclusion criteria
- Associated coeliac disease - Associated thyroid diseases - Associated cardiopathies - Long-term drug therapies
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
Primary objective: evaluate the efficacy of coenzyme Q in protecting oxidative stress in children with trisomy 21. To reduce susceptibility to infections, reduce the probability of developing leukaemia, and to slow down precocious aging in patients with Down's Syndrome with the use of Q-10 enzyme.
Primary outcomes
Plasmatic hydroperoxides Electrophoresis


Summary of study design, objectives, and ongoing research findings
Coenzyme Q10 has been available in Italy for a long time and is used to treat congenital Coenzyme Q10 deficits. The drug is well-tolerated. The main objective of this study is to evaluate the efficacy of this drug in protecting against oxidative stress in children with trisomy 21. Forty children aged 4-12 years, with trisomy 21, will be enrolled and will be randomised into one of two treatment groups. The study will last 6 months. The placebo group will also have a blood test performed, and this represents the extent of pain the children will be exposed to. The stady is intended to be of therapeutic benefit, even though it is not known yet whether the protection against oxidative stress, if any, will result in a clinically relevant benefit.