Trial reportNutrients2026
Plasma and Brain-Derived Extracellular Vesicle Biomarkers Following a Randomized Controlled Trial of Choline for Neurodevelopment in Fetal Alcohol Spectrum Disorder: A Pilot Analysis.
Trial report in Nutrients, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02735473 (Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundPostnatal choline supplementation improves memory, non-verbal IQ, executive function, and white-matter microstructure in children with fetal alcohol spectrum disorder (FASD) across randomized controlled trials; however, peripheral and brain biomarkers of these effects are uncharacterized.
methodsWe measured eight immune and neurotrophic biomarkers (TNFα, transferrin receptor 1 [TfR1], BDNF, ferritin, MCP-1, RANTES, CRP, and Eotaxin) in plasma and brain-derived extracellular vesicles (BDEVs) from 24 children with FASD randomized to choline (
resultsPlasma MCP-1 showed a nominally significant Group × Time interaction (
conclusionsIn this small, exploratory sample of children with FASD, a condition characterized by brain iron deficiency and inflammation, choline was associated with an attenuated rise in pro-inflammatory plasma MCP-1 relative to placebo, generating a new hypothesized candidate biomarker for further study. Most BDEV markers changed over time (Pre-to-Post), not with treatment. Plasma and BDEV BDNF were not significantly associated overall, although a between-person association was present without a corresponding within-person signal, suggesting that inferring central nervous system function from plasma BDNF should proceed with caution. These hypothesis-generating findings support further, larger-scale investigation of BDEV content analysis as a candidate complement to this trial program's cognitive and neuroimaging outcomes. Replication and expansion of the BDEV panel of analytes in a larger sample are needed.
trial registrationClinicalTrials.Gov [NCT02735473]; registered 2 April 2016.
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