The 20th century had folic acid, the 21st will have vitamin D
Encinitas, CA (March 29, 2018) – A petition has been submitted to the Food and Drug Administration (FDA) to certify a health claim on the association of vitamin D and decreased risk of preterm birth. If approved, this would be the third vitamin health claim allowed since the Nutrition Labeling and Education Act of 1990 required health claims to meet FDA regulations. The first is the approved health claim that ‘adequate vitamin D and calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis’. The second is that ‘healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect’.
The desired health claim, as specified in the petition to the FDA, is, “Pregnant women who have higher serum vitamin D levels have a decreased risk of preterm birth. Adding a vitamin D3 supplement to your healthy diet can help increase your serum vitamin D levels. Your healthcare practitioner can measure your serum vitamin D levels and determine the appropriate dosage of vitamin D3 for you.”
“If 50 percent of preterm births could be prevented each year in the United States, there could be nearly $6 billion available for other health services and more than 225,000 families would be spared this trauma,” said Karen Howard, CEO and Executive Director of Organic & Natural Health Association. “The Medical University of South Carolina has changed its standard of care for its pregnant patients and is now monitoring vitamin D levels based on their research. We are confident that members of Congress, their constituents, health insurers and employers will see the value in this health claim related to vitamin D levels and a reduced risk of preterm births.”
Organic & Natural Health Association has partnered with GrassrootsHealth to take the available research on vitamin D and preterm birth to Capitol Hill. The process of having an authorized health claim certified is no small feat. It involves garnering ‘significant scientific agreement’ on the claim. The folate claim was certified in 1996.
Part of the claim for folate was to identify neural tube defects as a significant risk to the population. Next, scientific evidence was presented that folate reduces the incidence of neural tube defects, referencing two separate randomized controlled trials (RCTs). Finally, a suggested amount and upper limit was defined. The FDA approved the health claim in March 1996, 31 years after the first research connecting folate to neural tube defects. The US government started fortifying grains with folate in 1998. An evaluation by the Centers for Disease Control in 2015 showed a 25% decrease in neural tube defects by 2005, and this level remaining constant. This effort is considered a success.
In 2006, researchers at the Medical University of South Carolina (MUSC) published data showing that the then current vitamin D recommended intake was not sufficient to meet the nutritional needs of pregnant women. Since then those same researchers performed two different RCTs with vitamin D and pregnancy. A third study, designed as a more comprehensive field trial, was done by GrassrootsHealth and MUSC and results were published in 2017. This study, called Protect our Children NOW!, tested, supplemented and reported results for all pregnant women seeking care at MUSC, over 1,000 women. The results of the field trial confirmed the results of the previous RCTs – vitamin D levels at or above 40 ng/ml (100 nmol/L) reduced preterm births 40-60%. The March of Dimes and other organizations confirm that preterm birth is a big problem in the US. Vitamin D could have the same, or bigger, effect on healthy pregnancy outcomes in the 21st century as folate did in the 20th century.
“Vitamin D is inexpensive and has been shown to be safe at the recommended level,” said Carole Baggerly, Director of GrassrootsHealth. “We have several medical centers ready to implement a new standard of care which mirrors this health claim. When I present this research to hospitals, insurers, and health care centers I get significant scientific agreement.”
GrassrootsHealth and Organic & Natural Health Association will be on Capitol Hill April 12 to meet with Congressional staff from across the country and share the story of how vitamin D reduces preterm birth and the need for FDA to approve this health claim. To review the FDA submission click here.
GrassrootsHealth is a non-profit public health research organization committed to moving vitamin D research into practice. It was founded in 2007 when Director Carole Baggerly realized that vitamin D research existed that could possibly have prevented her breast cancer. GrassrootsHealth partners with 48 senior vitamin D researchers from around the world and spearheads methodologies for nutrient research like analyzing results by serum levels rather than oral intake of vitamin D. It disseminates vitamin D research findings to the public and public health officials.