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ACHRI, UAMS Researchers Publish Largest Case-Control Study on Link Between Folic Acid Fortification and Neural Tube Defects

Publication Date: Thursday, October 30, 2008

(LITTLE ROCK, ARK.) Oct. 29, 2008 – A study led by investigators at the Arkansas Center for Birth Defects Research and Prevention and to be published in the American Journal of Epidemiology has discovered that the current level of folic acid fortification in the nation’s food supply may have reached a benchmark optimal for preventing many neural tube defects among the general U.S. population.

Researchers at the Arkansas Center for Birth Defects Research, a program housed at the Arkansas Children’s Hospital Research Institute (ACHRI), led the multi-center, case-control study. Using data from the National Birth Defects Prevention Study, they interviewed 565 women whose pregnancies were affected by neural tube defects, including spina bifida and anencephaly, and 3,963 women with unaffected pregnancies. Maternal intake of folate, both in the diet and in supplements, was compared between NTD-affected and unaffected pregnancies.

The findings are published in the American Journal of Epidemiology via Advance Access at http://aje.oxfordjournals.org/cgi/reprint/kwn331?ijkey=lsLzjC1V6KaretC&keytype=ref. The research also will appear in a future printed issue of the publication.

For more than three decades, epidemiologic research has reported that folic acid consumption reduces a woman’s risk of a pregnancy affected by a neural tube birth defect. In 1998, the U.S. Food and Drug Administration mandated that all enriched cereals and grain products be fortified with additional folic acid. As a result, the rates of neural tube defects have decreased.

Controversy regarding the optimum level of fortification has been ongoing. Questions remain as to whether all women are being exposed to enough folic acid to stop all preventable neural tube defects.

“Among participants in the National Birth Defects Prevention Study, the current level of folic acid fortification appears to be working,” said Charlotte Hobbs, MD, PhD, director of the Arkansas Center for Birth Defects Research and Prevention at ACHRI. “We still want women to take their additional daily supplement of folic acid to further reduce their chances of neural tube defects and birth defects.”

Hobbs, who also is a professor in the Department of Pediatrics at the University of Arkansas for Medical Sciences (UAMS) College of Medicine and section chief of Birth Defects Research, said the study is good news for the nation’s young women.

The study led by Arkansas investigators found little evidence of a link between neural tube defects and dietary folate intake or use of a folic acid supplement.

“This result was surprising to CDC scientists, national experts studying folic acid, as well as to us,” Hobbs said. “One explanation for our findings is that food supply fortification reduced the occurrence of folic acid-sensitive neural tube defects. Though more research will be needed to confirm this, that concept would indicate a ceiling or plateau effect.”

“We are encouraged that folic acid fortification has been so successful, but are concerned that certain groups of women, such as women from Hispanic backgrounds and women who are obese, still might not be getting enough folic acid,” says Dr. Edwin Trevathan, Director of the Centers for Disease Control’s National Center on Birth Defects and Developmental Disabilities. “It’s crucial that we continue to promote the importance of consuming at least 400 micrograms of folic acid daily to women of childbearing age, so we can continue to reduce rates of this debilitating condition of the brain and spine, especially in high-risk groups.”

The study looked at infants conceived after the 1998 folic acid fortification of the food supply. Among 180 anencephalic babies, 21.1 percent of their mothers reported using folic acid supplements before birth. Among 385 infants born with spina bifida, 25.2 percent of their mothers reported taking the supplement, and among the 3,963 unaffected babies, 26.1 percent of their mothers indicated they had taken folic acid while pregnant.
These findings were not statistically different in the investigators’ analysis.

The researchers also noted that folic acid has many implications beyond reducing the risk of spina bifida and anencephaly. Studies are showing its effect on congenital heart defects and cleft lip and palate, as well as other adverse pregnancy outcomes like prematurity. Whether there are optimum levels of folic acid to prevent these conditions is not known.

“We don’t want women to think they receive enough folic acid simply by eating their typical diet,” Hobbs said. “The strong recommendation is that women should continue to take their folic acid supplement and eat a healthy diet.”

The infants and mothers examined in the study were participants in one of the National Birth Defects Prevention Study’s 10 center sites in Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, North Carolina, Texas or Utah. The National Birth Defect Prevention Study is supported by funding from the Centers for Disease Control and Prevention.

Efforts to increase folic acid consumption among Arkansas women have resulted in a 33 percent decrease in the number of Arkansas births affected by neural tube defects. Similar levels of reduction of neural tube defects have been reported across the country. These prevention efforts have saved millions of dollars as the estimated lifetime cost of caring for a child affected by a neural tube defect is $600,000.

Arkansas Children’s Hospital is the only pediatric medical center in Arkansas and one of the largest in the United States serving children from birth to age 21. The campus spans 29 city blocks and houses 316 beds, a staff of approximately 500 physicians, 80 residents in pediatrics and pediatric specialties and more than 4,000 employees. The private, nonprofit healthcare facility boasts an internationally renowned reputation for medical breakthroughs and intensive treatments, unique surgical procedures and forward-thinking medical research - all dedicated to fulfilling our mission of enhancing, sustaining and restoring children's health and development. ACH recently ranked No. 76 on FORTUNE 100 Best Companies to Work For®. For more information, visit www.archildrens.org.

ACHRI provides a research environment on the ACH campus to meet the needs of the UAMS faculty. Research scientists at ACHRI conduct clinical, basic science, and health services research for the purpose of treating illnesses, preventing disease and improving the health of children everywhere.

UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, six centers of excellence and a statewide network of regional centers. UAMS has about 2,538 students and 733 medical residents. Its centers of excellence include the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute for Research and Therapy, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute and the Donald W. Reynolds Institute on Aging.
It is one of the state’s largest public employers with about 9,600 employees, including nearly 1,000 physicians who provide medical care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS’ Area Health Education Centers throughout the state. UAMS and its affiliates have an economic impact in Arkansas of $5 billion a year. For more information, visit www.uams.edu.

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