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The Challenge of Studying Supplementation: Omega Fatty Acids to Prevent Preterm Birth and Associated Complications

January 30, 2018
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Dietary supplements: it seems that medical professionals either love them or hate them. And while much research shows that the average healthy adult with a good diet probably doesn’t need them, studies of specific supplements in specific patient populations may show efficacy.

For example, studies show that omega-3 fatty acid supplements can reduce inflammation and improve risk factors for cardiovascular disease.

Researchers who are interested in other conditions linked to inflammation – for example, autism and preterm birth – are investigating how omega fatty acid supplementation may play a role in improving outcomes.

At Nationwide Children’s Hospital, research focused on omega fatty acids in the Center for Perinatal Research and the Center for Biobehavioral Health aims to overcome some of the challenges that have plagued investigators in the past and find accessible solutions for patient populations where options are limited.

“One of the biggest challenges this area of research faces is inconsistencies between previous studies,” says Lynette Rogers, PhD, principal investigator in the Center for Perinatal Research. “If you look at the research on omega fatty acid supplementation in neurodevelopmental disorders alone, the methodologies and supplements used are so diverse that a meta-analysis is nearly impossible.”

Dr. Rogers, who is also a professor at The Ohio State University College of Medicine (OSUCOM), is part of a multi-institutional team investigating the use of docosahexaenoic acid (DHA), an omega-3 fatty acid, to prevent preterm birth. Called the ADORE (Assessment of DHA On Reducing Early preterm birth) clinical trial, it is in its third year of data collection.

The ADORE trial aims to determine the impact of supplementation in pregnant women. The overall goal is to determine whether omega-3 fatty acid supplementation will lengthen gestation in women who give birth preterm. Investigators are tracking preterm births, inflammation biomarkers and collecting detailed information about the women’s diet.

The influence of diet, in fact, is one of the great challenges of this research. Ratios and amounts of omega fatty acids can vary tremendously from one person’s diet to the next.

“If you are giving everyone the same supplement, and they are eating whatever they would normally eat, it can be really difficult to know what fatty acids are actually in the blood and available for the body to use,” says Kelly Sheppard, PhD, post-doctoral scientist in the Center for Biobehavioral Health. “Variation in diet may explain why omega fatty acid supplements really help in some cases but not others.”

Sarah Keim, PhD, principal investigator in the Center for Biobehavioral Health, along with Drs. Sheppard and Rogers, have been working to study the impact of omega fatty acid supplements on developmental outcomes in toddlers born prematurely. The two studies – Preemie Tots and Omega Tots – focus on specific patient populations.

The Preemie Tots clinical trial examines the effect of omega fatty acid supplements on toddlers at risk for autism spectrum disorder. The Omega Tots clinical trial is a broader, larger study of children at least 1 year of age who were born preterm.

Researchers use a variety of methods to try to quantify omega fatty acids in the diet, including photographing meals, making a plate for the lab at each meal, extensive dietary recall exercises and food journals.

“In our studies of toddlers, understanding diet can be especially challenging,” says Dr. Keim, who is also an associate professor of Pediatrics at OSUCOM and Epidemiology in the College of Public Health. “Two-year-olds don’t clean their plates. And how much of the food ended up on the floor? We try to improve our ability to learn about diet with each new study.”

"Two-year-olds don’t clean their plates. And how much of the food ended up on the floor? We try to improve our ability to learn about diet with each new study." – Sarah Keim, PhD

According to Dr. Rogers, the moms-to-be in the ADORE study participate in extensive dietary recall exercises to address the dietary omega-3 contribution.

Finally, looking at specific measures and outcomes brings clarity to the results.

“Global measures, such as ‘Did the supplement improve developmental outcomes for premature infants?’ don’t always help us understand the influence of fatty acids well,” explains Dr. Sheppard. “We need to bring in the specific measures, gestures, executive function, and so on to help us see what fatty acid supplementation is good for – to help us understand where they are helping.”

Sometimes, studies do not see benefits or change when they use broad measures of development. This is counter to what is expected based on studies of omega fatty acids in animal models. However, by looking at specific abilities, researchers may see where the benefits lie. By considering ways to improve the studies, to look at independent variables and to account for additional influences on outcomes, researchers are moving closer to understanding the impact of omega fatty acids on preterm birth and infant and early childhood development.

“Our ability to collect and analyze data enables us to understand the impacts of supplementation in ways we haven’t been able to before,” says Dr. Keim. “For developmental outcomes, this goes beyond diet and includes the child’s environment. For example, we know that language development is influenced by stimulation and reading. By collecting data about the environment, we can further parse the data surrounding outcomes related to supplementation.”

Drs. Keim and Rogers will open a new clinical trial in 2018 to look at how omega fatty acid supplements impact biomarkers related to inflammation and ASD.

“Our key areas of focus are on populations and health outcomes where there are no other interventions,” says Dr. Keim. “We’re trying to offer something that is, first and foremost, evidence-based and, secondly, fairly accessible and easy to do.”