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A Letter from the Director, Carole Baggerly

4/5/18

Dear All,

Following is some preterm birth documentation, for your delight!

First, some links to documents that I think are worth looking at:
1.    A poster presented last year at the vitamin D workshop
2.   A powerpoint presentation that Dr. Roger Newman presented in February 2018 to the Birth Outcomes Initiative in South Carolina

(I like starting with pictures)

Publications

Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. 2011
https://www.ncbi.nlm.nih.gov/pubmed/21706518
This is the one that ‘started’ it for GrassrootsHealth.  We got the data, re-analyzed according to serum level and, had very significant results with preterm births.One of the key items that caught our attention was “…at least 100 nmol/L (40 ng/ml) required to support maximum 1,25(OH)2D output in the pregnant women.”

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. 2015
https://www.ncbi.nlm.nih.gov/pubmed/26554936?dopt=Abstract
GrassrootsHealth did all the data analysis and wrote the publication.

Maternal 25(OH)D concentrations ≥40 ng/mL associated with 60% lower preterm birth risk among general obstetrical patients at an urban medical center. 2017
https://www.ncbi.nlm.nih.gov/pubmed/28738090
GrassrootsHealth 1st publication with results from the Field Trial that we designed for MUSC.  This is the paper from the poster in the email.  The Protect our Children NOW! is a complete protocol for changing the standard of care for OB patients.  Of special note, ongoing, is that once you get the vitamin D level of the black population to the same level as as the Caucasian (40-60 ng/ml), the so-called socio-economic issue goes away.

We will have a new paper out soon re the 2nd year of the Field Trial–we are tracking ongoing — data is in the same direction, higher D is related to lower preterm birth rate.  Obviously, with ‘only’ 40-60% prevention, there are still other factors but this is the biggest, easiest one to implement.

Vitamin D status indicators in indigenous populations in East Africa. 2013
https://www.ncbi.nlm.nih.gov/pubmed/22878781
Results: The mean ± SD 25(OH)D of non-pregnant adults and cord serum were 106.8 ± 28.4 and 79.9 ± 26.4 nmol/L, respectively. Pregnancy, delivery, ethnicity (which we used as a proxy for sunlight exposure), RBC-DHA, and age were the determinants of 25(OH)D. 25(OH)D increased slightly with age. RBC-DHA was positively related to 25(OH)D, notably 25(OH)D₂. Pregnant MA (147.7 vs. 118.3) and SE (141.9 vs. 89.0) had higher 25(OH)D than non-pregnant counterparts (MA, SE). Infant 25(OH)D at delivery in Ukerewe was about 65 % of maternal 25(OH)D.
Note: ng/ml = 0.4 * nmol/L
This is especially noteworthy to see that the indigenous populations had serum levels in the same range as our scientists panel recommends: 100-150 nmol/L or 40-60 ng/ml.  Please note the INCREASE in vitamin D during pregnancy.

IOM Recommendation

A key item that will come up is the IOM/NAS recommendation of 20 ng/ml being ‘enough’ for bone health.  This has been challenged by us with Dr. Keith Baggerly, Biostatistician of MD Anderson, doing a presentation (and paper) at their conference last May on Reproducibility.  Keith very clearly laid out the error that the IOM had made in their calculations.

Late this last year, the NAS actually acknowledged the mistake but, in a following statement, made the conclusion that ‘it didn’t matter’. The evaluation was done by a committee, 2 of which were on the original committee — a very serious conflict of interest.

I hope you will take the time to watch it.  It is very ‘moving’!

We have decided to ‘ignore’ the problem for the time being since we have so clearly demonstrated for pregnancy that 20 ng/ml is grossly inadequate.  I can provide you more information if you wish.

https://www.youtube.com/watch?v=y33I8Zb55Rw
The Phase I report is here
https://www.nap.edu/resource/13050/Vit%20D%20panel%20report%20final.pdf
The Phase II report is here
https://www.nap.edu/resource/13050/FINAL%20Vitamin%20D%20Phase%20II%20Panel%20Report_11-17-17.pdf

 

Last, but not least as another concern

There is another issue that is very interesting with the efficacy of the 17p – hydroxyprogesterone that the MOD has been recommending:

17-alpha Hydroxyprogesterone
 caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study. 2017
https://www.ncbi.nlm.nih.gov/pubmed/28223163
From UT Southwestern Medical School, Dallas.  
CONCLUSION: 
17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.
This is a very serious issue, and a very costly one–currently, it costs the insurance company about $50k for a single pregnancy!  and, to have it be both ineffective as well as associated with gestational diabetes is major.  Their study was 4 years and 430 women.  We are tracking this efficacy in the MUSC Field Trial but don’t have enough data yet to draw any conclusions.

 

There are so many papers I could refer you to… just a generic look on pubmed.gov with Hollis vitamin D will show you a long list!  I will share more about ‘how to evaluate the research’ in my upcoming presentation in DC.

Onwards.

Carole

Carole A Baggerly
Director
GrassrootsHealth
2016 Humanitarian Award Recipient
from the American College of Nutrition for
Moving Research into Practice
619-823-7062