Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
- Conditions
- Fetal Alcohol Syndrome (FAS)
- Interventions
- Dietary Supplement: Epigallocatechin gallate
- Registration Number
- NCT02558933
- Lead Sponsor
- Parc de Salut Mar
- 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
1. Cognitive and neuropsychologic diagnostic scales of FAS
2. Determination of values of oxidative stress
3. Determination of control biomarkers of the treatment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- FAS diagnosed children between 7 and 14 y.o.
- Included in a previous cohort (ALMAR)
- Informed consent by parents
- Refuse of parents to participate
- Unfulfillment of inclusion criteria
- Any condition in children preventing from FAS diagnostics tests application
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epigallocatechin gallate (EGCG) treated Epigallocatechin gallate 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
- Primary Outcome Measures
Name Time Method Change in values of cognitive and neuropsychologic diagnostic scales of FAS 18 months (0, 4, 6, 12 and 18 months)
- Secondary Outcome Measures
Name Time Method Change of values of oxidative stress biomarkers 18 months (0, 6, 12 and 18 months)
Trial Locations
- Locations (1)
Parc de Salut Mar
🇪🇸Barcelona, Spain