Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02558933
• Date of registration: 22/09/2015
• Prospective Registration: Yes
• Primary sponsor: Parc de Salut Mar
• Public title: Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children Neuro-SAF
• Scientific title: Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
• Date of first enrolment: March 2016
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02558933
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Oscar Garcia-Algar, PhD
• Affiliation: Parc de Salut Mar

Key inclusion & exclusion criteria

Inclusion Criteria:

1. FAS diagnosed children between 7 and 14 y.o.

2. Included in a previous cohort (ALMAR)

3. Informed consent by parents

Exclusion Criteria:

1. Refuse of parents to participate

2. Unfulfillment of inclusion criteria

3. Any condition in children preventing from FAS diagnostics tests application



Age minimum: 7 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fetal Alcohol Syndrome (FAS)

Intervention(s)

Dietary Supplement: Epigallocatechin gallate

Primary Outcome(s)

Change in values of cognitive and neuropsychologic diagnostic scales of FAS [Time Frame: 18 months (0, 4, 6, 12 and 18 months)]

Secondary Outcome(s)

Change of values of oxidative stress biomarkers [Time Frame: 18 months (0, 6, 12 and 18 months)]

Secondary ID(s)

2014/5553

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundación Mutua Madrileña