7 completed, 1 active not recruiting, 1 recruiting. 9 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 7, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 4 | Completed 4 |
Follow Fetal Alcohol Spectrum Disorders: new trials by email Literature Review of Fetal Alcohol Spectrum Disorders trials Research Report on Fetal Alcohol Spectrum Disorders
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure Choline bitartrate, Placebo - Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome | Phase 2 | Recruiting | Wayne State University | 288 | 2023-04-13 | 2026-07-09 |
| Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study Choline Bitartrate - Fetal Alcohol Spectrum Disorders | Phase 2 | Active not recruiting | Jeff Wozniak | 62 | 2021-10-22 | 2026-07-08 |
| Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Choline bitartrate, Placebo - Fetal Alcohol Spectrum Disorders | Phase 2 | Completed | University of Minnesota | 46 | 2016-06-01 | 2022-11-01 |
| Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders Choline, placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water - Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome | Phase 2 | Completed | San Diego State University | 55 | 2013-05-01 | 2014-08-01 |
| Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure Choline bitartrate, Placebo for choline bitartrate - Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome | Phase 1 / Phase 2 | Completed | University of Minnesota | 60 | 2010-07-01 | 2016-12-19 |
| Project CHOICES Efficacy Study Brief Motivational Counseling - Risk for an Alcohol-Exposed Pregnancy, Hazardous Alcohol Use | Phase 2 | Completed | Centers for Disease Control and Prevention | 1200 | 2002-07-01 | 2005-09-12 |
| Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND) neurocognitive habilitation - Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder | Phase 1 / Phase 2 | Completed | Centers for Disease Control and Prevention | 100 | 2002-01-01 | 2011-03-24 |
| Fetal Alcohol Syndrome: Socio-Cognitive Habilitation math, behavior regulation - Fetal Alcohol Syndrome | Phase 1 / Phase 2 | Completed | Centers for Disease Control and Prevention | 100 | 2001-10-01 | 2008-04-28 |
| Fetal Alcohol Syndrome/ARND Research Consortion Parent-child Interaction Therapy (PCIT) - Fetal Alcohol Syndrome | Phase 1 / Phase 2 | Completed | Centers for Disease Control and Prevention | 100 | 2001-10-01 | 2008-04-28 |
Alcohol-Induced Disorders (1) · Alcohol-Related Disorders (1) · Binge Drinking (1) · Pregnancy Complications (1)
Chemically-Induced Disorders (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Female Urogenital Diseases and Pregnancy Complications (9) · Fetal Diseases (9) · Substance-Related Disorders (9) · Urogenital Diseases (9) · Alcohol-Induced Disorders (8) · Alcohol-Related Disorders (8) · Pregnancy Complications (8) · Mental Disorders (2) · Alcohol Drinking (1) · Behavior (1) · Drinking Behavior (1)
Choline (5)
Centers for Disease Control and Prevention (4) · University of Minnesota (2) · Jeff Wozniak (1) · San Diego State University (1) · Wayne State University (1)
United States (8) · South Africa (1)
Jeffrey R Wozniak, Ph.D. (3) · Ernesta M Meintjes, PhD (1) · Ira Chasnoff, MD (1) · Jennifer D. Thomas, Ph.D. (1) · John Mulvihill, MD (1) · Joseph L Jacobson, PhD (1) · Karen Ingersol, PhD (1) · Mark B Sobell, PhD (1) · Mary V. Velasquez, PhD (1) · Michael Georgieff, M.D. (1) · R. Colin Carter, MD, MMSc (1) · Rosa L Floyd, DSN (1) · Sandra W Jacobson, PhD (1)
PMID 39956364, PMID 20375733, PMID 22251828, PMID 26447156, PMID 27806977, PMID 32164522, PMID 33876196, PMID 36526961, PMID 42797005
R01AA024123 (2), R21AA019580 (1)