What is a Nutrient Field Trial?
GrassrootsHealth Nutrient Research Institute has implemented the world’s largest vitamin D nutrient field trial, D*action, since 2008, and has since grown to include other important nutrients and health markers. The D*action project is 100% virtual, with participants signing up via our web site, answering their online health questionnaire, and completing an at-home blood spot test which is mailed in and results are posted to their online account. They learn their nutrient levels and provide valuable health information for research as well as for their own education about what health and nutrient actions work for them. A variation of the project is defined for medical centers or institutions, as described below.
Do you want to participate? Choose the project that best fits you
Focus on General Health – do you know your vitamin D level?
In 2007, when GrassrootsHealth was formed, it was very hard to get a vitamin D test from your doctor, even though research was surfacing on the benefits of vitamin D levels in the range 40-60 ng/ml (100-150 nmol/L).
The D*action field trial was born. Now with over 15,000 self-subscribed participants, D*action not only helps people take charge of their health from the comfort of their home, it provides much needed peer-reviewed research on a vitamin D replete cohort. (The average vitamin D serum level of participants in D*action is 44 ng/ml, as compared to 25 ng/ml in the normal population).
Focus on Vitamin D & Omega-3s – Just as with vitamin D deficiency, omega-3 deficiency can put you at risk for chronic disease.
Over 23,000 published research papers support positive health benefits of high omega-3s, with more than 6000 supporting cardiovascular benefits, over 1000 showing respiratory benefits, and more than 2000 showing a benefit to diabetes conditions. Hundreds of studies suggest that omega-3 may provide benefit for a wide range of diseases, including asthma, depression, ADHD, autoimmune diseases, and cancer. Higher omega-3s have been associated with improved cognitive function, lower risk of dementia, longer life, and a reduced relative risk for death from any cause. They are beneficial for normal vision, anti-aging, skin health, maternal health, immune system, brain health, heart health, normal liver function, joints and muscles.
This project includes an Omega-3 Index blood spot test along with your vitamin D test. An Omega-3 Index between 8% and 12% was associated with lower risk for death from cardiovascular disease, versus an index less than 4%.
Magnesium*PLUS Focus Project- How are the essential nutrients vitamin D, omega-3s, and magnesium working for you?
Over 45% of the US population consumes less than the average daily requirement of magnesium, thus are very likely deficient. By participating in this project, you will learn your individual response to supplementation via blood testing and analysis of a detailed questionnaire and monthly tracking of symptoms.
Everyone experiences a unique response to supplementation or nutrient intake called the dose-response, which can be due to factors such as current health conditions, digestive health, co-nutrient status, medications, genetics and more. Measuring your nutrient status, adjusting intake as needed, and re-testing is the only way to tell if your nutrient intake is helping you achieve sufficient or desired nutrient status which is tied to particular health outcomes. We will analyze the collected data and publish scientific papers on key results, the first after meeting an enrollment target of 1000 participants.
Focus on Breast Cancer- Are you a woman of any age with no current cancer?
Multiple studies have shown that raising vitamin D levels to the recommended range of 40-60 ng/ml (100-150 nmol/L) could reduce the incidence of breast cancer by 50-80%. GrassrootsHealth is running a field trial to test this hypothesis. Women 60 years or older, with no current cancer, and not currently being treated for cancer are allowed to join. The field trial monitors their vitamin D blood levels and health condition every 6 months for 5 years.
Preliminary results of this trial were presented at the American Society for Nutrition’s Annual Meeting in 2014. After following 844 women for 18 months, GrassrootsHealth found an 80% lower rate of breast cancer among those women with vitamin D levels ≥ 50 ng/ml compared to those < 50 ng/ml.
Focus on Pregnancy – Are you 12-17 weeks pregnant and interested in joining our vitamin D study?
Research and nutrient field trials have found that vitamin D levels greater than 40 ng/ml (100 nmol/L) during pregnancy, starting as early as possible (even pre-conception) may lower incidence of preterm birth, gestational diabetes, post-partum depression, preeclampsia, and more.
By joining this study you will test your vitamin D levels at three time points in your pregnancy and fill out health questionnaires for both you and your newborn.
Focus on Type 1 Diabetes Prevention – Are you not yet diagnosed but positive for one or more of the islet cell autoantibodies?
An increasing body of evidence has shown that chronic inflammation can cause or advance many common chronic diseases, such as diabetes, with higher levels of cellular inflammation indicating a greater risk of the development of and/or accelerated progression towards chronic disease. The combination of tests in this project can be used to help track and manage inflammation. Test included are the vitamin D test, Omega-3 Index, AA:EPA Ratio, hsCRP and HbA1c.
This project will help identify potential changes in T1D diagnosis and autoantibody status that may result from vitamin D and omega-3 fatty acid testing and education, as well as provide additional education about islet autoantibodies, inflammation, and other T1D related information.
Do you want to run a nutrient field trial in your institution?
Lower Costs and Improve Health Outcomes
Research demonstrates one potential complication of vitamin D deficiency in pregnancy is preterm birth. Preterm births are closely associated with cerebral palsy, mental impairment and permanent hearing loss among other deficiencies. According to the March of Dimes, approximately 9.6% of all babies in the US are born prematurely and carry an extra health care burden of $50,000 for hospital costs alone. Research has shown that raising vitamin D levels in pregnant women > 40 ng/ml can reduce over 50% of preterm births compared to women with levels < 20 ng/ml.
Protect our Children NOW! is a well-defined nutrient field trial for a hospital or clinic. A new standard of care is born allowing all pregnant women receiving prenatal care at that location to be screened for vitamin D deficiency and to raise their serum levels to at least 40 ng/ml as soon as possible during pregnancy. Educational materials for medical staff and patients are included, as well as an onsite project manager. It is typically funded by the location and/or insurance companies – as the project cost is much less than the projected health care savings.
GrassrootsHealth provides a proven implementation model, tools, research and findings within 24 months.
- Test vitamin D levels and maintain ≥ 40 ng/ml
- Lower preterm birth rates
- Reduce costs
Contact GrassrootsHealth about starting a clinical innovation project today.
Protect our Children NOW! Case Study from the Medical University of South Carolina
2015 to Present
Starting September 2015, the Medical University of South Carolina, under the direction of Dr. Roger Newman, has implemented GrassrootsHealth’s Protect our Children NOW! nutrient field trial in their practice.
Every mother that comes to one of their clinics for treatment, thousands of mothers per year, receives a 25(OH)D test during their first prenatal visit (typically 12-14 weeks gestation). After reviewing the results, their OB may recommend supplementation to increase vitamin D levels, usually starting with 5000 IU vitamin D / day (their average entry vitamin D level is 20 ng/ml or below). Vitamins are free to patients under the program, thanks to the sponsorship of Bio-Tech Pharmacal, Inc. The OBs continue to monitor blood levels to ensure > 40 ng/ml throughout the pregnancy, typically testing again at 24-28 weeks and again at 34 – 36 weeks.
Note: Before the project began, 80% of all their patients and 100% of their African American patients were below 40 ng/ml.
Education of all of their OBs, over 20 doctors and health care providers, has occurred through free online continuing medical education (CME) courses provided by GrassrootsHealth. Educating the entire staff at MUSC was an important part of the project, so that all of the staff could buy into the new standard of care.
Educational materials are also provided for the mothers to help them understand the importance of taking their supplements. An onsite project manager assists in the education and follow through of all aspects of the program with staff and patients.
Not only did MUSC house the groundbreaking researchers – Drs. Carol Wagner and Bruce Hollis – but they also had support and funding from Select Health of South Carolina.
In the video below Dr. Newman explains how the Protect our Children NOW! vitamin D nutrient field trial works at the Medical University of South Carolina. Since September 2015, about 3,350 women received care and over 2,400 patients received at least one vitamin D test during this time. (Now, as the program is more established, all pregnant women receive vitamin D screening.)
Delivery information available for 1,387 women who had at least one vitamin D test during pregnancy, shows the same reduction in preterm birth seen in the earlier clinical trials. Preterm births decreased as vitamin D levels increased, up to 40 ng/ml, and then flattened out.
“56% lower risk for preterm birth (<37 weeks) for those with 25(OH)D > 40 ng/ml vs. < 20 ng/m (P<0.0001).”
There will be a paper published in the first half of 2017 with the results and Dr. Roger Newman hopes to continue this nutrient field trial indefinitely. Now that the results are in the staff at MUSC are even more bought-in to the project. In addition, we are searching for other divisions of the hospital, i.e. neurology, cardiology, to start a similar program.
Contact GrassrootsHealth about starting a clinical innovation project today.