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

NCT03624556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-06-11

No results posted yet for this study

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).

Conditions

  • Down Syndrome
  • Fragile X Syndrome

Interventions

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.

Sponsors & Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER

  • Instituto Hispalense de Pediatría, Sevilla, Spain

    collaborator UNKNOWN

  • Hospital Universitario Marqués de Valdecilla

    collaborator OTHER

  • Institut Jerome Lejeune

    collaborator OTHER

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2020-03-29
Completion
2020-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624556 on ClinicalTrials.gov