US admits math mistake was made in 2010 in estimating Vitamin D, but will not change recommendations – Nov 2017

Email from Keith Baggerly 11/21/17

Keith Baggerly kabagg at mdanderson.org is the son of Leo and Carol Baggerly of GrassrootsHealth

Just the facts.
About a year ago, concerns were raised about mathematical errors in the
Insitute of Medicine (IOM) report on vitamin D. These errors could have
led to recommended intakes being set too low.

In response, the National Academies of Science, Engineering, and
Medicine (NASEM) convened expert panels to review the issue in
two phases. In the first phase, one expert panel was asked to
determine whether or not statistical errors were indeed present.
The second phase would kick in if the first was answered in the
affirmative. In the second phase, another expert panel (with
some overlap with the first panel) would be charged with determining
if and how the IOM report's recommendations should be changed in light
of the errors identified.

The reports from these two phases are now posted on the web page for the original report
http://www.nationalacademies.org/hmd/Reports/2010/Dietary-Reference-Intakes-for-Calcium-and-Vitamin-D.aspx

The links are near the bottom of the page, in the paragraph

> Note: In response to claims of methodological errors in this report after its release, the National Academies undertook a two-phased review process to identify whether errors had been made and if so what effect those errors had on the findings. Here are the reports of the two review panels: Phase I and Phase II.

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

The report has been issued. Keith (Baggerly) is looking in depth which you are certainly encouraged to do as well. It's a big question now as to what we should do. Carole (Baggerly)

The bottom lines:

• The first panel agreed there were indeed mathematical errors in the IOM report.
• The second panel, however, found that the errors identified would not have affected the final recommendations made, so these remain unchanged.

On Wed, Nov 22, 2017 at 9:12 AM, Keith Baggerly <kabagg@gmail.com> wrote:
http://www.nationalacademies.org/hmd/Reports/2010/Dietary-Reference-Intakes-for-Calcium-and-Vitamin-D.aspx

The links are near the bottom of the page, in the paragraph

> Note: In response to claims of methodological errors in this report after its release, the National Academies undertook a two-phased review process to identify whether errors had been made and if so what effect those errors had on the findings. Here are the reports of the two review panels: Phase I and Phase II.

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

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Comment on the above email from Canada
"How was it not viewed a conflict of interest to have a committee member on the second panel, responsible for determining if RDA should be adjusted, who was the Chair of the committee that produced the initial 2010 IOM report under investigation???"

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Comments by Founder of VitaminDWiki, Henry Lahore

The Phase 2 report is an excellent example of bafflegab
   baf·fle·gab: "incomprehensible or pretentious language, especially bureaucratic jargon"
Some interesting phrasing from the Phase II study

• "This panel accepted as given the choice of bone health as the only health outcome"
• ". . it is impossible to say with complete certainty whether and/or how the committee’s collective judgment might have changed had the errors not been made"
• " . . the panel thinks it unlikely that this result would have changed the determination of the RDA for vitamin D/"
• "The SACN and EFSA reports,. . . used a risk assessment framework and both used the literature review and conclusions of the IOM report as a starting point"
• "In addition, the extent to which the conclusions of the IOM report influenced the recommendations of the SACN and EFSA reports is unknown."

Very circular reasoning:
1) US decided how much was needed in 2010
2) Europeans made decisions how much to recommend, starting from the US recommendations
3) US in 2017 says US must be right, even if the math was wrong, the Europeans agree with our recommendations
Many problems with SACN and EFSA

• UK (SACN) is ignoring scores of Vitamin D studies has the following

1. The SACN has cherry-picked data;
2. The SACN has not taken into account the problems with vitamin D intake studies;
3. The SACN has misinterpreted available data on the effects of genetic polymorphisms on vitamin D requirement;
4. The SACN has not sufficiently accounted for the effects of increased body weight and use of sunscreens;
5. The SACN has ignored expert evidence;
6. The SACN has ignored differences between vitamin D2 and D3;
7. The SACN has ignore emerging evidence for the role of elevated vitamin D status on reducing the risk of certain cancers;
8. The SACN has not proposed different recommendations for different racial groups/skin colours,
9. The SACN has not considered that there are likely to be overlapping risks and benefits;

• EFSA Vitamin D recommendations should reduce Rickets (but not much else) - March 2016

Reminder: Doctors have at least 10 reasons to be reluctant to increase vitamin D: which has the following quote

• It is difficult to get a man to understand something when his salary is dependent upon his not understanding it Upton Sinclair

Many studies have found that even bones need more than 600 IU

• Less bone loss if take 100,000 IU vitamin D monthly – RCT Nov 2017
• More calcium in bones in those teenage girls getting 2,000 IUs daily – RCT Jan 2016
• Hip bone loss stopped with 1000 IU of vitamin D, while 400 IU similar to placebo – RCT April 2013

They continue to ignore the non-bone benefits of vitamin D

• Chronic Hives treated by Vitamin D - many studies
• Gestational Diabetes reduced with 50,000 IU of vitamin D every 3 weeks and daily Calcium – RCT June 2014
• Respiratory infections reduced by 63 percent with 4000 IU vitamin D daily - RCT Dec 2012
• 500,000 IU of vitamin D cut in half the hospital days following a lung failure – RCT 2015
• Chronic Heart Failure reduced by 4,000 IU daily for a year – RCT April 2016
• Musculoskeletal pain reduced with 4,000 IU of vitamin D – RCT April 2015
• 1000 IU should be the new vitamin D RDA (if you think 20 ng is enough) - May 2017
• 1,100 IU Vitamin D needed to get most to 20 ng (look at individual not summary data) – April 2018
• Vitamin D supplementation guidelines (adults – 50,000 IU per week) – Feb 2017 Poland
• Vitamin D: not just bone, but also immunity – July 2016
• Intervention - Vitamin D 822 Interventions
• Vitamin D consensus: 400 IU for infants, less than 10 ng is too low, if low sun need to supplement – April 2017 has nice summary chart
  

• Consensus Vitamin D category listing has 69 items along with related searches
• Proof that Vitamin D Works has the following - only 2 of these were known in 2009 when IoM data was assembled

ADHD,  Alcoholic Liver Cirrhosis,  ALS,  Alzheimer's,  Antibiotic Use in Seniors,  Asthma,  Autism,  Autoimmune Diseases,   Back pain,  Blood Cell Cancer,   Breast Cancer,   Cardiovascular,  Cholesterol,  Chronic Hives,  Chronic Kidney Disease,  Cluster Headaches,  Congestive Heart Failure (Infants),  COPD,  Crohn's Disease,  C-Section and Pregnancy Risks,  Cystic Fibrosis,  Depression,   Diabetes,  Diabetic Neuropathy,  Eczema,   Falls,  Fatigue,  Fatty Liver (Child),  Fibromyalgia,  Gestational Diabetes,  Gingivitis,  Growing Pains,  Hay Fever,  Heart Attack,  Hemodialysis,  Hepatitis-C,   Hip Fractures,  Hypertension,  Influenza,  Irritable Bowel Syndrome,  Ischemic Stroke,  Knee Osteoarthritis,  Leg Ulcers,   Low Birth Weight,  Lupus,  Male Infertility,   Menstrual Pain,  Metabolic Syndrome,  Middle Ear Infection (Infants),  Mite Allergy,  Multiple Sclerosis,  Non-Alcoholic Fatty Liver Disease,  Osteoarthritis,  Parkinson's Disease,  Perinatal Depression,  Pneumonia (Ventilator-associated),  Poor Sleep,  PreDiabetes,  Preeclampsia,  Pre-term Birth,  Prostate Cancer,  Quality of Life,   Raynaud's Pain,   Respiratory Tract Infection,  Restless Leg Syndrome,   Rheumatoid Arthritis,   Rickets,  Sarcopenia,  Sepsis,  Short Neonates,  Sickle Cell,  Stronger Senior Muscles,  Survive ICU,  TB,  Tonsillitis,  Trauma Death,  Traumatic Brain Injury,  Tuberculosis,  Ulcerative Colitis,  Urinary Tract Infection,  Vaginosis,  Vertigo,  Warts,  Weight Loss

Reminder: Translate icon in the upper right selects a different language
Click on underlined items for details

Health Problem	Treat Prevent	Reduction by Vit D	RCT = Randomized Controlled Trial    * = link to additional RCT CT = Clinical Trial
Hypertension	T P	149 to 142 mm Hg HT risk reduced 10X	RCT*  *, 2400 IU.  100,000 IU* When Vitamin D > 40 ng
Cardiovascular after attack	T	32 % fewer deaths	CT 1000 IU
Diabetes Type 1	P	85 %	12,000 kids, 2000 IU
Diabetes Type 2	T	62 %	RCT* CRP reduction, 4000 IU Injection is far better - RCT * RCT 50,000 IU/2weeks + probiotics RCT 5,000 IU daily 6 months
Back Pain	T	95 % reduced 50%	5000/10000 IU 60,000 IU weekly
Influenza	P	90 %	RCT *, 2000 IU
Falls	P	50%	RCT, 100,000 IU monthly RCT with Meals on Wheels 2016
Hip Fractures	P	30 %	RCT * 800 IU
Rickets	P	98 %	Turkey, 400 IU NOT RCT, given to all children
Raynaud's Syndrome	T	40 %	RCT, visual scale, 20000 IU Avg
Menstrual pain	P	76 %	RCT, 7000 IU Avg, 70% reduction 2018 PMS reduced by half
Pregnancy risks	P	50 %	RCT, 4000 IU
C-section, unplanned	P	50 %	RCT, 4000 IU, small study
Low birth weight	P	60 %	RCT * 1000 IU of D2
TB	P	60 %	RCT, 800 IU
Breast Cancer	P	60 %	RCT, 1100 IU (2007)
Rheumatoid Arthritis pain	T	40 %	RCT, 500 IU, added to prescription
Cystic Fibrosis	T	75 % 2nd study improved	RCT, pilot 4X fewer deaths 250,000 IU RCT, pilot 8,200 IU
Chronic Kidney	T	90 to 70 PTH	RCT, 3500 IU,
Respiratory Tract Infection	P	63 %	3 RCT, 4000 IU 1 year 2nd 2000/800 IU 20,000 IU weekly
Lupus	T T	zero flares Pain reduced	Loading then 100,000 IU monthly, RCT too RCT 4,000 IU
Sickle Cell	T	Less pain	RCT, up to 100,000 IU/week
Leg ulcer healing	T	4X faster	RCT, 50,0000 IU/week, small study
Traumatic Brain Injury	T	2X	RCT, 20,0000 IU/day with progesterone
Parkinson's Disease	T	Stabilized	RCT, 1200 IU/day
Multiple Sclerosis	P T	68% 95% were CURED	RCT, 7100 IU prevent pre-MS ==> MS 20,000 to 140,000 IU/day
Congestive Heart Failure	T	90 %	RCT, 1000 IU infants (also: Adults, not RCT)
Middle Ear Infection	P	30 %	RCT, 1000 IU infants
Gingivitis	T	88 %	RCT, 2000 IU
Muscle in seniors	T	17 % more muscle	RCT, 4000 IU
Antibiotic use when >70y	T	47 %	RCT, 60,000 IU monthly
Infants taller	Benefit	1 cm tall	RCT, 50,000 IU weekly, for 8 weeks while pregnant
Gestational Diabetes	T	Reduced 3X	RCT, 2 doses of 50,000 IU
After Heart Attack	T	+6% ejection fraction	RCT, 800,000 IU one time
Prostate Cancer	T	Fewer +cores	RCT, 4000 IU (2012)
Asthma	P   T	Reduced symptoms	RCT, 60K IU/month; RCT 50K IU/week Need good D at 4 weeks into preg.
Depression	T	Reduced	RCT 300,000 IU injection RCT 1500 IU helped Prozac RCT 50,000 IU weekly, elderly
Low vitamin D while breastfed	P	All infants > 20 mg	RCT, 5,000 IU
Fibromyalgia	T	Half of many still has Fibro	RCT, 30-48 ng RCT 50K IU/week
Hives, Chronic	T	Reduced 40%	RCT, 4000 IU added
Cholesterol	T	Reduced 4 mg	RCT, 400 IU + Ca
Weight Loss	T	lost 5 more lbs	RCT, 2000 IU +diet +exercise
Gestational Diabetes	P	40%	RCT * , 5,000 IU
Chronic Obstructive Pulmonary Disease	T	17X improvement	CT, 50,000 IU weekly RCT 100,000 IU monthly
Asthma	T	1/2 Asthma attacks	RCT >42 mg of vitamin D
Quality of Life (QoL)	T	Nursing Home QoL	CT, 4,000 IU in daily bread
Death of Critically Ill Patients	T	20% increase in survivability	RCT 540 K IU loading than 90K monthly
Restless Leg Syndrome	T	Score 26 ==> 10	CT, Vitamin D dose size not stated in abstract
Hepatitis-C	T	Aided normal drugs	RCT 2.000 IU
Crohn's disease	T	improved when > 30 ng 2nd study fewer relapses	RCT 2,000 IU 10,000 IU RCT
Pre-term birth	P	2.5X decrease, also: fewer c-section & better Apgar	RCT 2,000 IU India
Cluster headaches	T	CH eliminated in 60%	10,000 IU, Mg, Omega-3, etc
Autism	T	80% improved	CT 300 IU/kg/day for 3 months
PreDiabetes	T	~20% reduced	RCT 60,000 IU/month
Weight loss: Overweight and Obese	T	12 lbs in 6 months	RCT 100,000 IU/month
Sarcopenia = muscle loss	T	27% increase	RCT 1,000 IU
Growing Pains	T	60% decrease	~100,000 IU/month -NOT RCT 2nd study, similar results
Osteoarthritis pain	T	60% decrease	50,000 IU/weekly - NOT RCT
ALS	T	helped	2,000 IU - NOT RCT, given to all
Vertigo	T	3X reduction if raised > 10ng	600,000 IU load, then maint. NOT RCT, given to all
Warts	T	80% eliminated injection	NOT RCT 60,000 IU/injection
Metabolic Syndrome	P	reduced 44% when VitD increased by 30 ng	NOT RCT, given to all
Hay fever	P	reduced 48%	RCT   1,000 IU for 30 days
Preeclampsia	P	Recurrance cut in half 3 RCT 3.6 X less likely if > 30 ng	50,000 IU every 2 weeks 4,000 IU daily
Blood cell cancer Multiple Myeloma	T	Survival 90% vs 50%	10,000 IU/week NOT RCT, given to all
Irritable Bowel Syndrome	T	Reduced	3,000 IU spray RCT
Urinary Tract Infection	P	50% reduction	RCT 20,000 IU weekly
Mite Allergy	P	5X reduction	RCT 2,000 IU preg, 800 IU child
Perinatal depression (depression near birth)	T	50% reduction	RCT 2,000 IU for just a few weeks
Vaginosis	T	10X reduction	RCT 2,000 IU
Eczema	T	Reduced	2 RCT 1,600 IU
Non-Alcoholic Fatty Liver Disease	T	Reduced	RCT 20,000 IU weekly
Knee Osteoartiritis	T	Pain Reduced	RCT 60,000 IU monthly after loading dose
Tuberculosis	T	Faster Recovery	RCT single 450,000 IU dose
Stroke - Ischemic	T	Faster Recovery	RCT single 600,000 IU injection RCT single 300,000 IU injection
Sepsis	T	Reduce ICU and Hospital length of stay by 7 days each	RCT 400,000 IU
Trauma deaths	T	50% fewer deaths	Vitamin D & Glutamine NOT RCT, given to all
Hemodialysis patients	T	helped	50,000 IU weekly NOT RCT, given to all
Fatty liver - child	T	2 X reduction	RCT  Vitamin D & DHA
Fatigue	T	Reduced	100,000 IU single dose NOT RCT, given to all
Sleep Disorders	T	Nicely treated	RCT  50.000 IU bi-weekly
Pneumonia (Ventilator-associated)	T	RCT   Death rate cut in half	300,000 IU injection
Infertile males	T	birth rate doubled	RCT   300,000 IU + maint
Waist size	T	Waist size reduced 3 cm	100,000 IU loading + maint for 6 months for those with Metabolic Syndrome NOT RCT, given to all
Attention Deficient Hyperactivity Disorder	T	Reduced Reduced	RCT  3,000 IU for 12 weeks RCT  50,000 IU weekly
Alcoholic liver cirrhosis	T	improved survival	1,000 IU of vitamin D NOT RCT
Diabetic nephropathy	T	Reduced HOMA-IR, FRS	RCT 50,000 IU weekly
Ulcerative Colitis	T	Reduced 60%	RCT 50,000 IU nano daily for a week
Obese weight loss	T	Lost 3X more pounds	$10 of Vitamin D added to   calorie restriction & walking
Endometriosis	T	Nicely treated	RCT  50.000 IU bi-weekly
Diabetic Wounds	T	4X more likely to heal	RCT  6,400 daily
Alzheimer's	T	Often reverse	Each person gets a different amount of Vit D, Omega-3, B12, Iron, etc
Autoimmune	P	Decrease 30%	RCT  Vit D + Omega-3
Smoking	T	reduce problems	RCT  50,000 bi-weekly
Tonsillitis	T	Virtually eliminated	RCT  50,000 weekly

Most proofs are RCT (Randomized Controlled Trials), where not even the doctor knows who gets it vitamin D

• 2 are meta-analyses of multiple RCTs
• Vitamin D was given to ALL infants in the entire country (Rickets) - not an RCT
• In several studies, researchers felt that it was unethical not to give vitamin D to everyone
• In some studies, the dose size varied with the needs of the person (overweight, etc)
• In some studies, the COFACTORS were adjusted to the needs of the patients
  • Curing requires the dose size and cofactors to be adjusted to the needs of each patient.

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Many Clinical Trials have not found a benefit because of one or more of the following failures:

1. Fails to use a large enough dose of vitamin D (often < 1,100 IU)
   The Even larger dose needed if: 1) obese, 2) poor gut, 3) sick (many diseases consume lots of vitamin D)
2. Fails to have given vitamin D for a long enough time (a few RCT lasted less than 5 weeks)
3. Fails to have given Vitamin D frequently enough. At least every 2 months for D3) - and at least weekly for D2
   Note: Infrequent dosing also causes unbalancing of the body's chemistry
4. Fails to provide a loading dose, or had too short a duration to restore the vitamin D levels
5. Fails to use D3 form, instead uses the less effective D2 form
6. Fails to have a healthy range of Calcium or other important cofactors (especially for bone-related trials
   Also, differences in Magnesium can result in 30% change in response to vitamin D
   Magnesium is dependent on water, food, supplements
7. Fails to notice the pre-existing vitamin D levels - only those who are low will likely show a benefit
8. Fails to notice how/when the vitamin D was taken (which can change the response by as much as 2X)
9. Fails to report on compliance (in one case 40% of the participants did not take the supplements consistently)

Many Meta-Analyses also do not find a benefit because one or more of the above failures
In addition, many meta-analysis average together ALL of the trials
Imagine a story about a meta-analysis of aspirin (which has never been done)
   There would be scores of RCT for aspirin not working with 3 mg doses
   There would be a many RCT of aspirin not working with 30 mg doses
   There would be a few studies of aspirin WORKING with 300+ mg doses
   There would be many studies of small amounts of Willow bark (Vitamin D2 instead of Vitamin D3)
   Then there would be a meta-analysis of aspirin and Willow Bark
   - That meta-analysis would conclude that aspirin and Willow bark do not work.

While about 200 RCTs will be published during 2014, I anticipate only adding 50 to the proofs table due to the reasons listed above
   Also, some trials will not get started due to lack of people willing to go for years with < 500 IU of vitamin D

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See also VitaminDWiki: Random Controlled Trials with vitamin D  intervention

• Intervention - Vitamin D 822 Interventions
  • Note: It sorts the interventions by health problem as well as by date
• Vitamin D intervention trials - a long list - May 2014 1204 trials
  2176 Vitamin D clinical trials as of June 2020: Nutrition Disorders 621, Vitamin D Deficiency 619, Malnutrition 601, Avitaminosis 586, Deficiency Diseases 583, **Metabolic Diseases 489. Musculoskeletal Diseases 362, Bone Diseases 317. Bone Diseases, Metabolic 282, Endocrine System Diseases 241. Osteoporosis 209, Immune System Diseases 190, Kidney Diseases 168, Communicable Diseases 164. Infection 164
  • Update Jan 2024   2835 Clinical Trials with Vitamin D
• Systematic Reviews or Meta-Analysis of Vitamin D 664 items
• 137 health problems associated with low vitamin D – meta-meta-analysis April 2014
• Intervention - 2-30 days 270 items

More intervention trials for Vitamin D than for the TOTAL of Vitamins A + C + K combined

Vitamin D = 2199, Others = 1803 Vitamin A 702 + Vitamin C 768 + Vitamin K 333    as of Aug 2020

See also VitaminDWiki

• Overview: Vitamin D also TREATS
• Is it ethical to not give vitamin D in osteoporosis trials– NEJM Sept 2010
  • Some Vitamin D RCT are not being created because the researchers do not want to deprive the benefits to half of the patients
  • Some Vitamin D RCT cannot be started because too many candidates are already taking vitamin D
• Reasons for Vitamin D deficiency
• List of all categories of Vitamin D Information and number of items in each
• List of all Overviews of Vitamin D 74 items along with related searches

CLICK ON chart for more information and translation

Vitamin D is especially needed during pregnancy

Most were taking 2,000 to 7,000 IU daily for >50% of pregnancy
   Click on hyperlinks for details

Problem	Vit. D Reduces	Evidence
0. Chance of not conceiving	3.4 times	Observe
1. Miscarriage	2.5 times	Observe
2. Pre-eclampsia	3.6 times	RCT
3. Gestational Diabetes	3 times	RCT
4. Good 2nd trimester sleep quality	3.5 times	Observe
5. Premature birth	2 times	RCT
6. C-section - unplanned	1.6 times	Observe
Stillbirth - OMEGA-3	4 times	RCT - Omega-3
7. Depression AFTER pregnancy	1.4 times	RCT
8. Small for Gestational Age	1.6 times	meta-analysis
9. Infant height, weight, head size      within normal limits		RCT
10. Childhood Wheezing	1.3 times	RCT
11. Additional child is Autistic	4 times	Intervention
12.Young adult Multiple Sclerosis	1.9 times	Observe
13. Preeclampsia in young adult	3.5 times	RCT
14. Good motor skills @ age 3	1.4 times	Observe
15. Childhood Mite allergy	5 times	RCT
16. Childhood Respiratory Tract visits	2.5 times	RCT

RCT = Randomized Controlled Trial

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Also, The Vitamin D Receptor limits the amount of Vitamin D in the blood actually gets to the tissue

The risk of 48+ diseases at least double with poor Vitamin D Receptor

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Short URL = is.gd/dproof

Short URL = is.gd/VitDMM