A new multicenter National Institutes of Health study will be conducted to determine whether an over the counter fatty acid supplement, called DHA (Docosahexaenoic acid, an omega-3 fatty acid), can assist with reducing early preterm births. The study will be monitored by a researcher Valentine and her colleagues.
"We know from preliminary studies that DHA is safe, well-tolerated and shows promise," says Christina Valentine, MD, a visiting professor at the University of Cincinnati College of Medicine, and a neonatologist and nutritionist who has spent the last 27 years looking at dietary interventions to impact health outcomes in the mother and preterm infant.
Preterm birth is one of the largest public health burdens globally, costing an estimated $26 billion in the U.S. annually, says co-investigator Emily DeFranco, DO, a physician-researcher at the Center for Prevention of Preterm Birth at Cincinnati Children's Hospital Medical Center and an associate professor of maternal-fetal medicine at UC.
Together UC, Ohio State University and the University of Kansas Medical Center will share this five-year, $3 million, Phase III clinical trial: Assessment of DHA on Reducing Early Pre-term Birth (ADORE). The multi-center project is funded through the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The trial will compare the birth outcomes of almost 1,200 women who take either 1,000 mg of DHA or the 200 mg of DHA per day during the second half of their pregnancy.
Valentine says the study was prompted by a prior human trial conducted by fellow principal investigators Susan Carlson, PhD, and Byron Gajewski, PhD, from the University of Kansas Medical Center. Carlson and Gajewski studied DHA in pregnant women, with a secondary finding that an adequate dose of DHA was associated with a five-fold reduction in early preterm birth.
While several factors contribute to preterm birth (smoking, alcohol and drugs), the UC researchers say that DHA might be the single most important preventive approach; considering that the average daily intake of DHA among healthy women in the U.S. averages 50 mg, says Valentine.
"For perspective, that's the level you would find in women living in impoverished third world countries," says Valentine.
The study is considered high yield/low risk, she says, because DHA is naturally occurring in fish, some eggs, and is an over the counter supplement found in fish oil, most prenatal vitamins, and baby formula.
"We are very excited to offer this promising prenatal intervention trial to improve health outcomes of pregnant mothers in Cincinnati. This has the potential to be the first treatment to reduce prematurity for all women, as our currently available therapies have proven benefit only in small subgroups of the highest risk women," says DeFranco.
The Dutch company Royal DSM is donating the DHA capsules to the study. Carlson has been a consultant to the company in the past, but the investigators have no current conflicts of interest.