February 9, 2017



 

Director's Letter 
Carole Baggerly 
Director, GrassrootsHealth 

It is time to initiate a call to action for all pregnant women. It is time to educate all pregnant women and OBs about a necessary change to standard of care. There is enough research, including a major nutrient field trial, confirming vitamin D levels above 40 ng/ml can greatly decrease the risk of preterm birth, setting children up for a healthier life.

How do we know this?

2006 - In this commentary, Drs Bruce Hollis and Carol Wagner lay out the importance of questioning the current vitamin D requirement for pregnant women, 200 IU/day, and lay out the premise that higher daily doses are both safe and necessary. This is a sort of treatise of things to come - the stake in the sand that will mark a change to standard of care for pregnant women.

2011 - Dr. Bruce Hollis, et al. published results from the Medical University of South Carolina's first randomized controlled trial on vitamin D supplementation during pregnancy with 350 women. This study showed that 4000 IU/day was not only safe, but also effective in raising vitamin D levels in pregnant women.

2013 - Dr. Carol Wagner, et al. replicated the study above using two new community sources and found similar results - 4000 IU was indeed safe, and no adverse effects were seen. This study also found an inverse relationship between preterm birth and vitamin D level.

2016 - GrassrootsHealth and Drs Wagner and Hollis published results comparing serum levels vs. rates of preterm birth using the data from their previous studies and comparing that to "normal" population results from the March of Dimes. This study showed that there was a decrease in preterm birth until about 40 ng/ml, and then reached a plateau. Indeed - that 40 ng/ml should be the target for pregnant women.

Present - Starting in September 2015, the Medical University of South Carolina, under the leadership of Dr. Roger Newman, implemented GrassrootsHealth's Protect our Children NOW! program - a new standard of care that tests pregnant women at up to 3 timepoints in pregnancy, educates them, and provides free vitamin D supplements if desired, to try and achieve 40 ng/ml. After seeing over 3000 women, the results were presented at this year's Society for Maternal-Fetal Medicine Pregnancy Meeting. The results almost exactly matched those of previous studies - on a bigger population!

What does this mean?

The time is now for more nutrient field trials to occur. For other organizations to change their standard of care so that all pregnant women are screened and encouraged to raise their vitamin D level to at least 40 ng/ml. 

We have been saying this, and most of you know it is true, but we can't wait for "more research" - we need to act now!
  • If you know a pregnant women - encourage her to join D*action, to find out how her level compares to others, for the sake of her pregnancy and of her unborn child.
  • If you know an OB - tell them to read this newsletter and the papers associated with it. To attend an upcoming conference at the Medical University of South Carolina and learn more. The lives of all of their patients depend on it.
  • If you support the March of Dimes - email them and let them know there is a way to prevent preterm birth and it isn't more studies - it is vitamin D - and it is NOW!
We are going to make a splash! So, join us, the water is warm.

Onwards!
 
Carole Baggerly 
Director, GrassrootsHealth 
A Public Health Promotion & Research Organization 
Moving Research into Practice NOW!
 
Field Trial Results CONFIRM RCT Findings

 
Preliminary Results from the Protect our Children NOW! Project

Roger Newman, MD
Director & Professor, Obstetrics & Gynecology
Vice Chairman for Academic Affairs & Research
Medical University of South Carolina
Presented at The Pregnancy Meeting
Society for Maternal-Fetal Medicine
January 2017
Watch Video

40 ng/ml is the right number!

Dr. Newman begins his talk by explaining a little about how vitamin D works within the body and how our current understanding of the role of vitamin D is much more extensive than what he learned in medical school. He also addresses existing controversy around different recommendations for "how much is enough" including the IOM recommendation that 20 ng/ml is enough. He stated that "the target goal for our patients needs to be a vitamin D level, ideally, between 40 to 60 ng/ml." 

Reviewed RCTs

He reviews the two RCTs done by Drs Hollis and Wagner - one of the key results being that 4000 IU/day is safe, no adverse effects were ever reported. During this review he presents data from the trials and highlights the variability seen at a specific dose and the importance of following up treatment with a new test to see how the individual has responded. He then shows charts, including one similar to the one below, that analyze the data by serum level rather than treatment group.


Notice how the curve starts to flatten off after 40 ng/ml? Again, these were the findings from the 2 RCTs, this is not new information.

What happened at the university?

Dr. Newman explained the Protect our Children NOW! vitamin D field trial that has been in motion 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)."

Are you an OB? 
Learn more...




Scientific Workshop on Vitamin D

Vitamin D in the Prevention of Health Disparities During Pregnancy and Early Infancy
Thursday, March 23
8am - 3pm
Medical University of South Carolina

Keynote: Vitamin D and the Placenta: Two Sides to the Story

Martin Hewison, PhD
Professor of Molecular Endocrinology
Deputy Director, Institute of Metabolism & Systems Research
Centre for Endocrinology, Diabetes & Metabolism
University of Birmingham (UK)
 

Moving Research into Practice
How to do effective nutrient field trials

Carole Baggerly, Director of GrassrootsHealth
 

Dr. Carol Wagner Results of the Medical University of South Carolina Field Trial -  Vitamin D and the co-morbities of pregnancy

Carol Wager, MD, Professor
Associate Director, Neonatal-Perinatal Fellowship Program
Associate Director, Clinical and Translational Research Center
 
Sign up now for this conference if you are an OB that wants to learn more about vitamin D and pregnancy and how to incorporate it into your practice. 

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Vitamin D in the Prevention of Health Disparities During Pregnancy and Early Infancy

Thursday, March 23
8am - 3pm
Medical University of South Carolina

Results Confirm RCT Findings

Roger Newman, MD
Presented at The Pregnancy Meeting
Society for Maternal-Fetal Medicine
January 2017



Nutritional vitamin D status during pregnancy: reasons for concern
Bruce Hollis, MD
Carol Wagner, MD
Medical University of South Carolina
Canadian Medical Association Journal
April 2006

Vitamin D Supplementation During Pregnancy: Double-Blind, Randomized Clinical Trial of Safety and Effectiveness
Bruce Hollis, MD et al.
Medical University of South Carolina
Journal of Bone and Mineral Research
October 2011

A Randomized Trial of Vitamin D Supplementation in Two Community Health Center Networks in South Carolina
Carol Wagner, MD et al.
Medical University of South Carolina
American Journal of Obstetrics & Gynecology
February 2013

Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates
Carol Wagner, MD et al.
Medical University of South Carolina
The Journal of Steroid Biochemistry and Molecular Biology
October 2015


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