Landmark Study Pushes Acceptance of Vitamin D Claim

vitamin d claim

Story at-a-glance -

  • Trade group the Organic & Natural Health Association (O&N) has submitted a petition to the U.S. Food and Drug Administration (FDA) that would allow vitamin D dietary supplements to make a health claim that they reduce the risk of premature birth
  • Vitamin D supplementation led to significant improvements in premature birth risk among pregnant women at an urban medical center
  • Women with vitamin D levels of 40 ng/mL or higher were 62 percent less likely to have a premature birth than those with levels below 20 ng/mL
  • Women with a history of premature birth were 80 percent less likely to have another premature birth when their vitamin D levels were 40 ng/mL or higher compared to those with levels below 20 ng/mL
  • Increasing vitamin D levels also helped with premature birth disparities among women of different race/ethnicities; among nonwhite women whose vitamin D levels were initially below 40 ng/mL, those who raised their levels to 40 ng/mL or above had a 78 percent lower rate of premature birth than those whose levels remained below 40 ng/mL for their entire pregnancy

By Dr. Mercola

In the U.S., there’s a baby born prematurely every 90 seconds.1 And despite spending more than $3 trillion on health care each year, it is the worst performing system ranked by multiple aspects of care,2 including premature births. Each year, premature births make up roughly 12 percent of U.S. births, which is the highest rate among developed countries.3

An easy-to-access and low-cost supplement — vitamin D — could drastically change the high rate of premature births in the U.S., however, even potentially closing the gap on premature birth disparities that exist between white women and African-American women.

Following the results of a landmark study, trade group the Organic & Natural Health Association (O&N) has submitted a petition to the U.S. Food and Drug Administration (FDA) that would allow vitamin D dietary supplements to make a health claim that they reduce the risk of premature birth.

Optimizing Vitamin D Levels Could Reduce Premature Births by 60 to 80 Percent

A collaborative study between the Medical University of South Carolina (MUSC) and nonprofit public health research organization GrassrootsHealth revealed that vitamin D supplementation led to significant improvements in premature birth risk among pregnant women at an urban medical center.4 During the 15-month study, 1,064 pregnancies were traced, with women receiving a vitamin D (25(OH)D test during their first prenatal visit along with a follow-up test later.

The treatment goal was to optimize the women’s vitamin D levels to 40 nanograms per milliliter (ng/mL) or higher, and free vitamin D supplements were offered for this purpose.

At the beginning of the study, 18 percent of single births at MUSC were premature, defined as delivery at less than 37 weeks. Over the course of the study, 13 percent of the pregnancies resulted in a premature birth. However, women with vitamin D levels of 40 ng/mL or higher were 62 percent less likely to have a premature birth than those with levels below 20 ng/mL.

The results were even more striking among women with a history of premature birth; this group was 80 percent less likely to have another premature birth when their vitamin D levels were 40 ng/mL or higher compared to those with levels below 20 ng/mL. Increasing vitamin D levels also helped with premature birth disparities among women of different race/ethnicities.

Overall, the rate of premature birth at MUSC was 10 percent for white women, 15 percent among all nonwhite women and 19 percent among African-American women.5 However, among nonwhite women whose vitamin D levels were initially below 40 ng/mL, those who raised their levels to 40 ng/mL or above had a 78 percent lower rate of premature birth than those whose levels remained below 40 ng/mL for their entire pregnancy.

Increasing Evidence Points to Importance of Vitamin D for Preventing Premature Birth

The MUSC/GrassrootsHealth study is but one of several recent studies that have highlighted vitamin D’s potential to reduce premature birth rates. In 2016, a study published in the Journal of Steroid Biochemistry and Molecular Biology revealed that women with vitamin D levels of at least 40 ng/mL had a 57 percent lower risk of premature birth compared to those with levels of 20 ng/mL or lower.6

The study revealed that gestation week at birth rose steadily with increasing vitamin D levels until plateauing when levels reached about 40 ng/ML. In 2015, separate research revealed a 51 percent lower risk of premature birth among women with a vitamin D level of 38 ng/mL or greater compared to those with levels of 8 ng/mL or lower.7

Beyond premature birth, there are many additional reasons to optimize vitamin D levels during pregnancy. According to GrassrootsHealth, achieving a vitamin D level of 40 to 60 ng/mL during pregnancy can lead to:8

There are benefits to babies, as well, including:

  • 70 percent lower prevalence of common cold
  • 66 percent lower prevalence of ear infections
  • 62 percent lower prevalence of lung infection
  • Improved language development
  • Reduction in Type 1 diabetes as an adult

Congress Urged to Allow Vitamin D Health Claim for Premature Birth Prevention

With the evidence mounting that optimizing vitamin D levels during pregnancy could have remarkable benefits for moms and babies, O&N turned to Congress, asking for their support of their FDA petition to allow a premature birth prevention claim for vitamin D. O&N executive director Karen Howard told Holistic Primary Care:9

“Overall, the response was highly enthusiastic. People had a good grasp of the need for vitamin D, and most had been tested, acknowledging they had been advised their levels were low and that they were using vitamin D supplements.

The statistics quickly grabbed attention in most of our meetings, with several showing amazement at the correlation between D and preterm births, and the outcomes generated from the MUSC data. We were also able to share the rate of preterm births for each state, bringing our message home quickly.”

O&N has urged members of Congress to send letters of support for the petition to FDA commissioner Scott Gottlieb, with Howard noting that some Congress members were immediately enthusiastic:10

“From these conversations we’ve begun to organize outreach to state delegations and other groups that could be logical allies. Needless to say, because of the research efforts by the Medical University of South Carolina, the SC delegation was particularly interested. Several agreed on the spot to send a letter to FDA.”

Monitoring Vitamin D Levels Should Be Standard of Care During Pregnancy

Based on their research, MUSC has already changed its standard of care for pregnant women to include routine monitoring of vitamin D levels. The hope is that if the FDA approves the vitamin D health claim, it would pave the way for women to become aware of the importance of vitamin D during pregnancy and make routine monitoring commonplace.

GrassrootsHeallth believes a new standard of care should be implemented for pregnant women that involves vitamin D testing three times during pregnancy and maintaining blood levels of 40 to 60 ng/mL.

Although such testing is not yet widespread, you can request a vitamin D blood test from your health care provider or enroll in GrassrootsHealth’s Protect Our Children NOW! project, which seeks to resolve vitamin D deficiency among pregnant women and children, and raise global awareness about the health risks associated with vitamin D deficiency.

The project was initiated by Carole Baggerly of GrassrootsHealth in 2015 and has a panel of 42 vitamin D researchers that provide scientific advice. If you are 12 to 17 weeks pregnant, at least 18 years of age and currently reside in the U.S., this fully sponsored study is available at no cost to you. Participation in the program includes:

  • Free vitamin D blood tests, which you can do from the comfort of your own home
  • Your and your newborn's new questionnaire entries
  • Reporting of results directly to you
  • Free vitamin D supplements

Enroll in Protect Our Children NOW! Program

If you are planning a pregnancy, or are more than 17 weeks pregnant, you can still take control of your and your child's health by using the D*Action test kit. It's one of the most cost-effective ways to monitor your vitamin D status. The minimum vitamin D level you're aiming for is 40 ng/mL, while additional research suggests a level between 60 and 80 ng/mL provides the greatest health benefits and widest protection against chronic disease.

Vitamin D Helps Prevent Chronic Disease

When you take steps to optimize your vitamin D, it’s not only your pregnancy that will benefit. For instance, vitamin D is known to be crucial in several areas of your body, as a deficiency has been implicated in such problems as macular degeneration, lupus, bowel diseases, multiple sclerosis and chronic heart failure.11 In addition, optimizing your vitamin D levels is one of the absolute best flu-prevention strategies available and can also slash your cancer risk.

Previous research found that a vitamin D level of 50 ng/mL was associated with a 50 percent lower risk of breast cancer.12 Further, researchers at University of California, San Diego School of Medicine reported that raising your vitamin D level to 40 ng/mL can slash your risk of all invasive cancers by 67 percent.13 Vitamin D also does wonders for your heart, as it triggers the production of nitric oxide, a molecule that helps control blood flow and prevent blood clot formation within your blood vessels.

Further, vitamin D significantly reduces oxidative stress in your vascular system, which can prevent the development of heart disease.14 It’s also important for your brain. In a six-year study that followed more than 1,600 people, vitamin D deficiency was associated with a substantially increased risk of dementia, including Alzheimer’s disease.15

In fact, people who were severely deficient in vitamin D had a 122 percent increased risk of developing dementia, whereas those who were moderately deficient were at a 53 percent greater risk. For Alzheimer’s disease specifically, being severely vitamin D deficient was linked to a 122 percent increased risk compared to a 69 percent increase for those who were moderately deficient.16

Breastfeeding Women Need to Monitor Their Vitamin D Levels Too

After birth, most doctors tell new parents to keep their babies in the shade for the first six months and to make sure they’re covered with either clothes or sunscreen when they do go outside. As such, breastfeeding babies are dependent on their moms to get enough vitamin D, but if mom is deficient, so too will be baby.

The American Academy of Pediatrics recommends breastfed infants be supplemented with 400 IU per day of vitamin D, but research conducted by Bruce W. Hollis and colleagues at the Medical University of South Carolina Pediatrics revealed that mothers supplementing with 6,400 IU per day of vitamin D would safely supply their breast milk with vitamin D to meet, if not exceed, her own and her nursing infant’s vitamin D requirements and be a safer alternative to supplementing the baby’s diet directly.17

But, as noted by GrassrootsHealth, “[I]t’s important, if depending upon breast milk, that you yourself take vitamin D every day. Just a day or two off vitamin D, and your breast milk content of vitamin D drops to very low levels.”18 When babies start life with a vitamin D deficiency, they will face probable growth, developmental and immune function challenges, not to mention an increased prevalence of disease as they get older.

GrassrootsHealth estimates that more than 80 percent of pregnant women are deficient in vitamin D, so the best time to start optimizing your levels is during pregnancy or, even better, before. Meanwhile, they recommend at least annual testing of vitamin D levels in children to be sure their levels are optimized as well.

Hopefully, the FDA will approve O&N’s petition for a vitamin D, premature birth health claim, which would be a game changer in terms of bringing this important connection to the public’s attention. In the meantime, you can take steps to optimize your vitamin D levels now, and if you want to support the petition, you can fill out this action alert to send a letter to your representatives in Washington asking for their support.

The best way to optimize your vitamin D level is through sensible sun exposure, but for many, oral supplementation will be necessary to achieve an optimal level, especially if you're pregnant during the winter.

Remember, the only way to accurately assess your need for supplementation is to measure your vitamin D level. Also keep in mind that if you take high-dose vitamin D, you may also need to increase your intake of calcium, magnesium and vitamin K2, as these four nutrients work in tandem and rely on sufficient amounts of each to work properly.

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