CTSI Supports Study That Evaluates Potential Treatment for Kids With Fetal Alcohol Spectrum Disorders
A University of Minnesota research team recently published the results of a clinical trial that showed choline could reduce some of the cognitive defects caused by prenatal alcohol exposure.
Children with fetal alcohol spectrum disorders (FASDs) who took a daily supplement of the water soluble nutrient showed small gains in memory performance, which could significantly impact their overall cognitive development.
“Rather than treating the symptoms of the condition, we are attempting to alter the trajectory of brain development in a way that could be permanent.”
The study, which was published in the American Journal of Clinical Nutrition earlier this month, is the first clinical trial to investigate choline’s effects on kids with FASDs, and could signal a new approach to treatment. The research team conducted the study using a wide range of CTSI resources.
“CTSI staff members were instrumental in the critical early design and Investigational New Drug (IND) application stages of the project,” says Dr. Wozniak. He adds that CTSI’s regulatory team also monitored the trial, which “provided our study with constructive oversight and feedback throughout its execution.”
The study used a pediatric exam room (shown) in the Delaware Clinical Research Unit, with CTSI’s clinical research support staff performing a variety of study procedures and implementing the protocol. In addition, Dr. Wozniak and team turned to CTSI for biostatistical support.
The Health Talk blog post described the study in more detail:
The randomized, double-blind, placebo-controlled trial studied the impacts of a choline supplement as a neurocognitive treatment for children with FASDs. Choline, a water-soluble nutrient, is most commonly associated with the vitamin-B complex, and can be found naturally in eggs, legumes, beef or nuts.
Clinical trial participants received a daily supplement for nine months through a fruit-flavored drink mix specially developed for the study. The choline group showed memory improvements compared to the placebo group.
The blog post also describes how Dr. Wozniak and collaborators will continue investigating the issue:
There are still several variables to study, like dosing, duration of treatment and best age for treatment.
Going forward, Wozniak will continue to study the original clinical trial participants who are now 5-10 years old to analyze long-term effects, and replicate the study with a new trial group to compare results through a $1.5 million NIH grant with Michael Georgieff, MD, professor in the Department of Pediatrics of the Medical School.
University researchers interested in conducting a health sciences study are encouraged to contact CTSI’s Research Navigator at 612-625-CTSI or firstname.lastname@example.org to discuss your needs from study planning and start-up to study close out.