Fatty Acid Supplementation in Children With ASD (Study 2)

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarah Keim
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Age 2-6 years old

• ASD diagnosis at Nationwide Children's Hospital within the prior 6 months

• ADOS-2 score in "autism" (severe) range

• English is primary language

Exclusion Criteria:

• Fatty acid supplementation in the past 6 months

• Consumes fatty fish more than 3 times per week

• Still breastfeeding or formula feeding

• Quadriparesis

• Deafness

• Blindness

• Seizure disorder diagnosis

• Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes, Tuberous Sclerosis

• Feeding problems precluding consumption of the supplement

• Ingredient allergy (canola, fish, or borage seed)

• Planned surgeries scheduled within the time frame of trial participation