NCT03624556

Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety and tolerability of epigallocatechin gallate (EGCG) in children from 6 to 12 years old with Intellectual Developmental Disorders (IDD) (Down syndrome or Fragile X syndrome).

Detailed description

This project first objective is to evaluate the safety and tolerability of the EGCG molecule (extracted form green tea) on children from 6 to 12 years old with Intellectual Development Disorder (Down syndrome and Fragile X syndrome). The secondary objective is to evaluate the benefits of the EGCG on attention, memory, executive functions, language and adaptive behaviour of these children. Dyrk1A and homocysteine in plasma will also be quantified, using them as biomarkers of efficacy.

Conditions

• Down Syndrome
• Fragile X Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EGCG FontUp	Intake of 10mg/kg/day of EGCG, in the form of a dietary supplement (FontUp), two times a day.
OTHER	Placebo FontUp	Intake of placebo, in the form of a dietary supplement (FontUp) (without EGCG), two times a day.

Timeline

• Start date: 2018-01-29
• Primary completion: 2020-03-29
• Completion: 2020-11-30
• First posted: 2018-08-10
• Last updated: 2021-06-11

Locations

1 site across 1 country: Spain