Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children (Neuro-SAF)
Primary Purpose
Fetal Alcohol Syndrome (FAS)
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Epigallocatechin gallate
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Syndrome (FAS) focused on measuring Fetal Alcohol Syndrome, Prenatal exposure, Biomarkers, Oxidative stress, Epigallocatechin gallate
Eligibility Criteria
Inclusion Criteria:
- FAS diagnosed children between 7 and 14 y.o.
- Included in a previous cohort (ALMAR)
- Informed consent by parents
Exclusion Criteria:
- Refuse of parents to participate
- Unfulfillment of inclusion criteria
- Any condition in children preventing from FAS diagnostics tests application
Sites / Locations
- Parc de Salut Mar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epigallocatechin gallate (EGCG) treated
Arm Description
Intervention: Epigallocatechin gallate (EGCG) administered FAS children: An oral dose of 9 mg/Kg/day of EGCG will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment
Outcomes
Primary Outcome Measures
Change in values of cognitive and neuropsychologic diagnostic scales of FAS
Secondary Outcome Measures
Change of values of oxidative stress biomarkers
Full Information
NCT ID
NCT02558933
First Posted
September 22, 2015
Last Updated
August 27, 2019
Sponsor
Parc de Salut Mar
Collaborators
Fundación Mutua Madrileña
1. Study Identification
Unique Protocol Identification Number
NCT02558933
Brief Title
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Acronym
Neuro-SAF
Official Title
Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Fundación Mutua Madrileña
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.
The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.
Detailed Description
Background
1% of children present a prenatal alcohol exposure related disorder. Prevalence of consumption increases every year. In a previous study in Barcelona, 45.5% of ethanol positive meconiums were detected, as a biomarker of maternal consumption of alcohol during pregnancy. The most serious clinical picture including facial, mental and cognitive disorders is Foetal Alcohol Syndrome (FAS). Spain is the second country in adoptions from East Europe, where the consumption of alcohol during pregnancy is most important. The only prevention of FAS is avoiding consumption of alcohol during pregnancy and there is no treatment for its deleterious effects on neurodevelopment.
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.
Objective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Methodology Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.
Instrumentalization
Cognitive and neuropsychologic diagnostic scales of FAS
Determination of values of oxidative stress
Determination of control biomarkers of the treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome (FAS)
Keywords
Fetal Alcohol Syndrome, Prenatal exposure, Biomarkers, Oxidative stress, Epigallocatechin gallate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epigallocatechin gallate (EGCG) treated
Arm Type
Experimental
Arm Description
Intervention: Epigallocatechin gallate (EGCG) administered FAS children: An oral dose of 9 mg/Kg/day of EGCG will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Epigallocatechin gallate
Intervention Description
Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of Epigallocatechin gallate (EGCG). It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.
Primary Outcome Measure Information:
Title
Change in values of cognitive and neuropsychologic diagnostic scales of FAS
Time Frame
18 months (0, 4, 6, 12 and 18 months)
Secondary Outcome Measure Information:
Title
Change of values of oxidative stress biomarkers
Time Frame
18 months (0, 6, 12 and 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FAS diagnosed children between 7 and 14 y.o.
Included in a previous cohort (ALMAR)
Informed consent by parents
Exclusion Criteria:
Refuse of parents to participate
Unfulfillment of inclusion criteria
Any condition in children preventing from FAS diagnostics tests application
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Garcia-Algar, PhD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26351940
Citation
Joya X, Marchei E, Salat-Batlle J, Garcia-Algar O, Calvaresi V, Pacifici R, Pichini S. Fetal exposure to ethanol: relationship between ethyl glucuronide in maternal hair during pregnancy and ethyl glucuronide in neonatal meconium. Clin Chem Lab Med. 2016 Mar;54(3):427-35. doi: 10.1515/cclm-2015-0516.
Results Reference
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PubMed Identifier
25903753
Citation
Vall O, Salat-Batlle J, Garcia-Algar O. Alcohol consumption during pregnancy and adverse neurodevelopmental outcomes. J Epidemiol Community Health. 2015 Oct;69(10):927-9. doi: 10.1136/jech-2014-203938. Epub 2015 Apr 22. No abstract available.
Results Reference
background
PubMed Identifier
25131946
Citation
Joya X, Garcia-Algar O, Salat-Batlle J, Pujades C, Vall O. Advances in the development of novel antioxidant therapies as an approach for fetal alcohol syndrome prevention. Birth Defects Res A Clin Mol Teratol. 2015 Mar;103(3):163-77. doi: 10.1002/bdra.23290. Epub 2014 Aug 18.
Results Reference
background
PubMed Identifier
23164116
Citation
Garcia-Algar O, Black D, Guerri C, Pichini S. The effect of different alcohol drinking patterns in early to mid-pregnancy. BJOG. 2012 Dec;119(13):1670-1. doi: 10.1111/1471-0528.12007. No abstract available.
Results Reference
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Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
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