Clinical research
The folinic acid trial — 48 children, and a measurable difference
What happened
Researchers ran a randomized, double-blind, placebo-controlled trial of folinic acid (a form of folate that can reach the brain by another route) in 48 children with autism and language impairment — the study design this library wishes every story could have.
What it looked like
Children with autism whose language was significantly impaired, some of whom carried folate receptor autoantibodies.
What the labs found
Children were tested for FRAAs, and the antibody-positive group turned out to be where the treatment effect lived.
What changed
Overall, the folinic acid group gained about 5.7 points more than placebo on the trial's measure (effect size d = 0.70). In the FRAA-positive subgroup, the gain was larger — about 7.3 points (d = 0.91). In FRAA-negative children, the difference was not significant. An independent trial summary (ASAT) reproduces the same responder split: 15 of 23 responders on treatment versus 6 of 25 on placebo.
The test that told the story
Folate receptor autoantibody (FRAA) testing — it predicted who responded.
Sources: Frye et al., randomized controlled trial (2016, with 2018 follow-up reporting); independent ASAT trial summary.