Trial reportThe American journal of clinical nutrition2016
Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders.
Trial report in The American journal of clinical nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01911299 (Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders), which is not on this map. Cited by 44 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 in Children With Fetal Alcohol Spectrum Disorders
Who cites it
44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.
- First Evidence-Based Guideline for Interventions in FASD.Neuropediatrics · 2025Pooled it
- Association between Maternal Choline, Fetal Brain Development, and Child Neurocognition: Systematic Review and Meta-Analysis of Human Studies.Advances in nutrition (Bethesda, Md.) · 2022Pooled it
- Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials.The American journal of clinical nutrition · 2025Trial
- Long-term follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder: corpus callosum white matter microstructure and neurocognitive outcomes.Journal of neurodevelopmental disorders · 2022Trial
- The impact of micronutrient supplementation in alcohol-exposed pregnancies on reaction time responses of preschoolers in Ukraine.Alcohol (Fayetteville, N.Y.) · 2022Trial
- Maternal choline supplementation mitigates alcohol exposure effects on neonatal brain volumes.Alcoholism, clinical and experimental research · 2021Trial
- Four-year follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder.Journal of neurodevelopmental disorders · 2020Trial
- Feasibility and Acceptability of Maternal Choline Supplementation in Heavy Drinking Pregnant Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Alcoholism, clinical and experimental research · 2018Trial
- Efficacy of Maternal Choline Supplementation During Pregnancy in Mitigating Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Alcoholism, clinical and experimental research · 2018Trial
- Choline status and related health outcomes in humans: A scoping review.Nutrition and health · 2026Article
- The Gut-Brain Axis in Fetal Alcohol Spectrum Disorder (FASD): Why the Gut Shapes Behavior, Depression, and Self-Injurious Behavior in Children with Prenatal Alcohol Exposure-A Narrative Review with a Proposal for Staged Nutritional and Microbiological Intervention.Journal of clinical medicine · 2026Review
- The NKCC1 Antagonist Bumetanide, Administered After Prenatal Alcohol Exposure, Mitigates Ethanol-Induced Aberrance in Tangential Migration of GABAergic Interneurons in Mouse Medial Prefrontal Cortex.Alcohol, clinical & experimental research · 2026Article
- Review
- Cognitive and transcriptomic effects of Epigallocatechin gallate in fetal alcohol spectrum disorders.Scientific reports · 2026Article
- Prenatal Exposure to Low Alcohol and Alcohol Motivation in the Offspring.Advances in experimental medicine and biology · 2026Review
- Article
- Regional hippocampal thinning and gyrification abnormalities and associated cognition in children with prenatal alcohol exposure.Journal of neurodevelopmental disorders · 2025Article
- Choline in immunity: a key regulator of immune cell activation and function.Frontiers in immunology · 2025Review
- Early moderate prenatal alcohol exposure and maternal diet impact offspring DNA methylation across species.eLife · 2024Article
- Developmental ethanol exposure produces deficits in long-term potentiation in vivo that persist following postnatal choline supplementation.Alcohol, clinical & experimental research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundPrenatal alcohol exposure results in a broad range of cognitive and behavioral impairments. Because of the long-lasting problems that are associated with fetal alcohol spectrum disorders (FASDs), the development of effective treatment programs is critical. Preclinical animal studies have shown that choline, which is an essential nutrient, can attenuate the severity of alcohol-related cognitive impairments.
objectiveWe aimed to translate preclinical findings to a clinical population to investigate whether choline supplementation can ameliorate the severity of memory, executive function, and attention deficits in children with FASDs.
designIn the current study, which was a randomized, double-blind, placebo-controlled clinical trial, we explored the effectiveness of a choline intervention for children with FASDs who were aged 5-10 y. Fifty-five children with confirmed histories of heavy prenatal alcohol exposure were randomly assigned to either the choline (n = 29) or placebo (n = 26) treatment arms. Participants in the choline group received 625 mg choline/d for 6 wk, whereas subjects in the placebo group received an equivalent dose of an inactive placebo treatment. Primary outcomes, including the performance on neuropsychological measures of memory, executive function, and attention and hyperactivity, were assessed at baseline and postintervention.
resultsCompared with the placebo group, participants in the choline group did not differentially improve in cognitive performance in any domain. Treatment compliance and mean dietary choline intake were not predictive of treatment outcomes.
conclusionsFindings of the current study do not support that choline, administered at a dose of 625 mg/d for 6 wk, is an effective intervention for school-aged (5-10 y old) children with FASDs. This research provides important information about choline's therapeutic window. Combined with other studies of choline and nutritional interventions in this population, this study emphasizes a further need for the continued study of the role of nutritional status and supplementation in children with FASDs and the contributions of nutrition to neurocognition. This trial was registered at clinicaltrials.gov as NCT01911299.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.