April 6, 2016

Director's Letter 
Carole Baggerly 
Director, GrassrootsHealth 

Today, April 6, 2016, is the release of a truly definitive paper about vitamin D and cancer.  In 2007, I read a paper by Lappe et al. and, cried.  It was a randomized controlled trial which showed a 77% cancer incidence reduction with all cancers (women) with a serum level of approximately 40 ng/ml vs a baseline of 28 ng/ml.  I was still recovering, mentally, from my own bout with breast cancer and treatment.  THIS was the answer to 'How do we PREVENT' cancer!  There was a way!!!  Unfortunately, it was not to be.  There were many obstacles that we faced with getting acceptance, and, most importantly, ACTION from this study.

In 2012, GrassrootsHealth initiated a Breast Cancer Prevention Project, which now has over 1000 participants, in order to add data to the Lappe study and to focus on the information from the serum levels of our cohort.

Our goal was to add our data about women and cancer to the existing data from the randomized trial to accomplish a major aim. GrassrootsHealth has a much larger sample of women with higher serum levels than the Lappe study, and together they would create a larger overall cohort with a broader range of serum levels.

Our major, novel steps for this research paper included:
  • pooling data from a randomized trial as well as a cohort study
  • analyzing the data by serum level vs. treatment group (how much D they took)
  • presenting multiple types of analysis--this was very important to show everyone that no matter how you looked at the data, the results were essentially the same!
We are very, very proud of the methodology in working this.  It was thorough and very precise.

End result:  a >65% reduction in cancer risk for all cancers in women by going from a serum level of 20 ng/ml to 40 ng/ml.  I would especially encourage you to look at the shape of the curve below.  There is a marked decline in risk going down from 20 ng/ml and a more gradual decrease as the serum level gets above 40 ng/ml.

My plea to ALL of you--please, please help get the attention of everyone to the idea that we CAN greatly reduce the risk of cancer by getting vitamin D levels to at least 40 ng/ml.  It's urgent, it's also very, very wasteful for no attention to be paid!  Help us take very aggressive action now!

Thanks so much for your ongoing participation in the D*action project. 

Carole Baggerly 
Director, GrassrootsHealth 
A Public Health Promotion & Research Organization 
Moving Research into Practice NOW!
New GrassrootsHealth Analysis Associates Vitamin D with >65% Lower Cancer Risk

Serum 25-Hydroxyvitamin D Concentrations ≥40 ng/ml are Associated with >65% Lower Cancer Risk: Pooled Analysis of Randomized Trial and Prospective Cohort Study
Presenting Poster at Workshop
Sharon L. McDonnell et al.
April 6, 2016

GrassrootsHealth has four researchers on staff capable of analyzing and publishing study data. We can use data from our three population cohorts - D*action, Breast Cancer Prevention, and Protect our Children NOW! and have partnerships with leading researchers who allow us access to their study data. For this paper we partnered with leading vitamin D and cancer researchers - Dr's Garland, Gorham, and Lappe as well as GrassrootsHealth Research Director, Dr. Heaney.
The Importance of Analysis by Serum Level
GrassrootsHealth believes in focusing analysis on achieved serum level rather than simply the amount of vitamin D a person gets per day (or week or month).  This is important for understanding the relationship between disease condition and vitamin D and has been missing from many published studies. This is the second research paper GrassrootsHealth has published where we have taken existing data and re-analyzed results based on serum levels, not dosage levels. The result? A clear understanding of how to prevent a condition with vitamin D.

What about Cancer?
For this analysis we combined data for women 55 and older from our GrassrootsHealth cohort (N = 1,135, median serum level = 48 ng/ml) and the cohort of a previously published RCT on vitamin D and calcium supplementation with respect to cancer (Read Lappe RCT paper; N= 1,169, median serum level = 30 ng/ml) and used the pooled cohort to investigate cancer incidence over time (median = 3.9 years).  Combining cohorts gave us a wider range of serum levels, more data, and thus improved statistical power. We looked at all invasive cancers combined, excluding skin cancer.

Using statistical analysis, we found that women with vitamin D serum levels ≥40 ng/ml had a 67% lower risk of cancer than women with serum levels <20 ng/ml. In the chart above you can see that the greatest decrease in risk occurred between ~10 - 40 ng/ml. Calcium did not have any significant effect on cancer risk in this analysis.  

Future Studies

In order to change standard of care and have consistent results, future studies should base their analysis on vitamin D status. They should analyze by vitamin D serum level, and not limit analysis to treatment group or dosage, and they should try to effect change over the complete response range (with overall cancer this seems to be between 10-40 ng/ml). 

19th Vitamin D Workshop
Boston, MA

Vitamin D Workshops bring together basic researchers, clinicians and nutrition experts from around the globe. It is a multi-day forum where the latest research on vitamin D is presented, debated and shared. The Workshops are organized by a dedicated group of internationally recognized scientists who are experts on vitamin D. They publish formal proceedings of the research papers in a special issue of the Journal of Steroid Biochemistry and Molecular Biology, after each workshop.

Eyes and Ears on the Ground: Christine French

Christine French joined GrassrootsHealth in 2009. She has been involved in verifying and analyzing vitamin D related data from D*action questionnaires, as well as from other sources, and preparing publications based on that data. With training in science education and public outreach, French has been instrumental in making GrassrootsHealth data accessible and understandable. She earned her bachelor's degree in biological sciences from UC Santa Barbara and MS in environmental sciences from UC Riverside. 

From Christine:

I was surprised to see that there were over twenty presentations - talks or posters - that had to do with some aspect of pregnancy. Some were related more directly to fertility (pre-pregnancy); while others looked at vitamin D during pregnancy or in the cord blood and how that could be related to various aspects in the infant (post-pregnancy); and others were concentrated on specific conditions of pregnancy itself.

Specific topics ranged from the time to conceive for women aged 30-44 with no known fertility problems, to placental gene expression in response to supplementation, risk of preeclampsia, even the impact of vitamin D deficiency on sleep quality in women during their first trimester of pregnancy.

Knowing that some responses or susceptibility to disease later in life are "programmed" during pregnancy (there was a presentation on this topic as well), it is good to see wide range of interest in vitamin D and pregnancy.  

It seems that much of this research related to pregnant women is due, at least in part, to the Hollis-Wagner study from several years ago that showed vitamin D was safe for pregnant women, which opened up the field to more study. While some of the research presented was focused on mouse models, most were on women and/or their infants.

Eyes and Ears on the Ground: Sharon McDonnell

Sharon McDonnell has been in the field of public health for ten years and has been an epidemiologist and biostatistician at GrassrootsHealth for the past three years.  She received a BS degree in Psychobiology from UCLA and an MPH in Infection Diseases, specializing in epidemiology and biostatistics, from UC Berkeley. 

From Sharon:

I was very excited to sit in on an update on the VDAART study, a pregnancy vitamin D supplementation trial.  Their original paper regarding asthma/wheezing in children at 3 years reported results based on treatment group, which showed a non-significant (20%) reduction in the incidence of asthma or recurrent wheeze among children in the treatment group (4400 IU/day) compared to the control group (400 IU/day). This finding was considered "not statistically significant" because it had a P-value of 0.051, which is 0.001 higher that the cut point for significance. We wrote about this in the January 27 newsletter and indicated we were interested in what the results would show when analyzed by serum 25(OH)D concentration rather than by treatment group. As you know, analyzing by serum level is one of our five nutrient RCT guidelines because it accounts for all input sources (sun, food, and supplements), overcomes the bias of treatment compliance, and makes provision for the inter-individual variability in dose response.

As expected, they found statistically significant results when analyzing the data by serum 25(OH)D concentration.  Children of women with baseline 25(OH)D concentrations greater than 40 ng/ml who were in the treatment group had an 85% lower risk of asthma/wheezing at age 3 than children of women with baseline 25(OH)D concentrations less than 20 ng/ml who were in the placebo group.  Children of women in the treatment group with higher third trimester 25(OH)D concentrations (≥30 ng/ml) had the lowest risk for developing asthma than any other group (P=0.02). They did not find a plateau in the effect; a consistent decrease in risk was observed to at least 80 ng/ml.

These findings show that it is important for mothers to have levels above 40 ng/ml at the start of pregnancy (because lungs start developing week 4) and maintain this level throughout pregnancy to significantly reduce the risk of asthma/wheezing in their children.

Note: We will report on this new analysis when it is published. This talk was a pre-cursor to publication. 
Editor's Letter
Susan Siljander
Marketing Director, GrassrootsHealth

Four of our GrassrootsHealth employees attended the 19th Vitamin D Workshop in Boston. I asked for summaries from many of them and I am very excited that pregnancy and serum level are all the rage! GrassrootsHealth presented a poster on cancer and vitamin D which is profiled in the main article this week.

What we need is for all researchers to heed the guidelines of Dr. Robert Heaney - and make sure serum level is central to vitamin D RCTs. When these guidelines are followed then we should see more consistent results for vitamin D.

Keep these things in mind if you hear negative press about vitamin D: Did they dose enough? Was it frequent enough? Did they test and analyze by serum level? Did they optimize co-nutrients? Usually one or more of these factors is missing.

Have a great week!

Susan Siljander
Marketing Director, GrassrootsHealth
A Public Health Promotion & Research Organization
Moving Research Into Practice NOW!
Order Now
Your participation in this project provides information for your answers to D questions and helps fund the GrassrootsHealth projects.

Joan Lappe
Creighton University

About the Lappe Cohort:
  • four years
  • double-blind
  • placebo-controlled
  • women aged 55 years and older
  • no known cancer at enrollment or within 10 years prior
  • 1500 mg/day Calcium
  • 1000 IU/day vitamin D
  • recorded cancer incidence over 4 years
Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial
Joan M. Lappe, et al.
American Journal Clinical Nutrition
June 2007

Vitamin D status in a rural postmenopausal female population
Joan M. Lappe, et al.
The Journal of the American College of Nutrition
October 2006

Research based on serum level

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 L. Wagner, MD, et al.
Medical University of South Carolina
The Journal of Steroid Biochemistry and Molecular Biology
November 2015

Serum 25-Hydroxyvitamin D Concentrations ≥40 ng/ml are Associated with >65% Lower Cancer Risk: Pooled Analysis of Randomized Trial and Prospective Cohort Study
Sharon L. McDonnell, MPH et al.
April 2016

It is important to look at study data by serum level. There are other important criteria in nutrient studies. Read the recommended best practices for nutrient studies and some analysis of studies that have been in the news.

Plasma 25-hydroxy vitamin D concentrations, vitamin D receptor genotype and breast cancer risk in a UK Caucasian population
Lowe LC, et. al.
St. George's Hospital Medical School, London
 European Journal of Cancer
May 2005

A hospital-based case control study showed that women with serum concentrations of  > 60 ng/ml had an 83% reduction in breast cancer risk compared to women with concentrations < 20 ng/ml.

Pretreatment serum concentrations of 25-hydroxyvitamin D and breast cancer prognostic characteristics: a case-control and a case-series study
Song Yao, et al.
Roswell Park Cancer Institute, New York
PLoS One
February 2001

A population-based case control study found a 63% lower risk of breast cancer for women with 25(OH)D concentrations ≥ 30 ng/ml compared to women with concentrations < 20 ng/ml, with a 71% lower risk among post-menopausal women.

Circulating Vitamin D Levels and Risk of Colorectal Cancer in Women
Chandler PD, et al.
Harvard Medical School
Cancer Prevention Research
August 2015

A recent nested case-control study found a 55% lower risk of colorectal cancer in women with 25(OH)D concentrations ≥ 29 ng/ml compared to women with concentrations < 18 ng/ml.

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