High-Dose Vitamin D Decreases Bone Mineral Density

I just posted about two large trials where high-dose vitamin D increased fractures and falls.

This one found that taking vitamin D decreased bone mineral density:

Effect Of High-Dose Vitamin D Supplementation On Volumetric Bone Density And Bone Strength, A Randomized Clinical Trial, JAMA, August 2019

In this randomized clinical trial that included 311 healthy adults, treatment with vitamin D for 3 years at a dose of 4000 IU per day or 10 000 IU per day, compared with 400 IU per day, resulted in statistically significant lower radial bone mineral density (BMD).

Even participants who took 400 IU had a reduction in bone mineral density.

If high-dose vitamin D does stimulate an increased rate of bone loss, this could have greater clinical significance [fracture risk] in older individuals with osteoporosis.

Fracture risk … Didn’t we just see that?

Another problem with taking vitamin D, especially with calcium, is that it can increase the amount of calcium in blood (hypercalcemia) and urine (hypercalciuria), which it did in this study. Too much calcium in urine is a common cause of kidney stones. Too much calcium in blood effects many systems, has many side effects.

There was a dose-response effect:

Episodes of hypercalcemia and hypercalciuria were more common with increasing vitamin D dose, consistent with previous reports.

Surprisingly, it also affected those in the 400 IU group:

However, in the 400-IU group that was following the National Academy of Medicine–recommended dietary allowance of calcium and vitamin D3, 17% had hypercalciuria on at least 1 occasion over the study duration.

Conclusions:

These findings do not support a benefit of high-dose vitamin D supplementation for bone health.

High Dose Vitamin D Increases Risk For Fractures And Falls

Lots of people are taking lots of vitamin D. Can you take too much? I happened across:

Is High Dose Vitamin D Harmful?, Calcified Tissue International, February 2013

With the potential to minimize the risk of many chronic diseases and the apparent biochemical safety of ingesting doses of oral vitamin D several-fold higher than the current recommended intakes, recent research has focussed on supplementing individuals with intermittent, high-dose vitamin D.

However, two recent randomized controlled trials (RCTs) both using annual high-dose vitamin D reported an increase, rather than a decrease, in the primary outcome of fractures.

Results from observational, population-based studies with evidence of a U- or J-shaped curve are also presented as these findings suggest an increased risk in those with the highest serum 25D levels.

Here are those two RCTs:

Effect Of Annual Intramuscular Vitamin D On Fracture Risk In Elderly Men And Women–a Population-Based, Randomized, Double-Blind, Placebo-Controlled Trial, Rheumatology, December 2007

Annual High-Dose Oral Vitamin D And Falls And Fractures In Older Women A Randomized Controlled Trial, JAMA 2010

The first one was out of the UK:

Randomized, double-blind, placebo-controlled trial of 300,000 IU intramuscular (i.m.) vitamin D2 (ergocalciferol) injection or matching placebo every autumn over 3 years. 9440 people (4354 men and 5086 women) aged 75 yrs and over were recruited from general practice registers in Wessex, England.

The vitamin D group showed an almost 50% increased risk of hip and femur (thigh bone) fractures compared with placebo group. Fracture risks were higher in women:

When the genders were analysed separately, the tendency for an increase in fracture risk was particularly observed among women, in whom there was a 59% increase in hazard at the proximal femur or distal forearm (wrist) among those treated with vitamin D compared with placebo (P = 0.003).

The second one was out of Australia:

Double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older … randomly assigned to receive cholecalciferol (vitamin D3, 500 000 IU, oral) or placebo each autumn to winter for 3 to 5 years.

Participants receiving annual high-dose oral cholecalciferol experienced 15% more falls and 26% more fractures than the placebo group. Women not only experienced excess fractures after more frequent falls but also experienced more fractures that were not associated with a fall.

I thought that the delivery method (very high dose once a year) might be having an effect. They think not:

The evidence of harm relating to high-dose vitamin D centers on the findings of two RCTs that used annual high-dose vitamin D (Table 3), although results from RCTs using lower, more frequent dosing regimens have not been consistently clear. The different forms of the vitamin used in the studies and the different delivery modes demonstrate that the adverse outcomes are not restricted to one form of the vitamin.

The mechanism for these increased falls and fractures isn’t understood. Sanders et al. speculates that vitamin D supplementation may result in a “decline in muscle strength” (there are vitamin D receptors in muscle). It may also impact the central nervous system (there are vitamin D receptors in CNS and the brain) affecting balance and coordination.

From Concluding Summary:

In addition to evidence from enzyme kinetics relating to vitamin D metabolism [44], there is now high-level RCT evidence that vitamin D supplementation has potential toxicities other than simply hypercalcemia/-uria.

Emerging evidence from both observational studies and RCTs suggests that there should be a degree of caution about recommending high serum 25(OH)D concentrations for the entire population.

Some notes about doses:

  • They defined high-dose as: “High dose refers to an intermittent bolus dose of at least 20,000 IU or a daily dose of 4,000 IU.”
  • 4000 IUs is 100 micrograms.
  • Conversion: 1 µg (microgram) = 40 IU (international units)
  • For comparison, 2000 IU a day is 60,000 IU a month is 720,000 IU a year is more than the 300,000 and 500,000 IU/year used in these trials.
  • “Peak 25(OH)D levels from these studies tend to be around 120-140 nmol/L (48-56 ng/ml).”
  • Conversion: One nmol/L is equal to 0.4 ng/mL, and 1 ng/mL is equal to 2.5 nmol/L.

So, high-dose vitamin D could be acting in the brain? Affecting balance and coordination? Isn’t that the last thing we need?

Journalistic Integrity: Kaput

Hank Aaron. Source: People

Hank AAron died seventeen days after receiving the Moderna COVID vaccine.

NYTs:

Fact Check: Hank Aaron’s Death Was Not Related to Covid-19 Vaccine

The Fulton County medical examiner has also said there was nothing to suggest that Mr. Aaron had an allergic or anaphylactic reaction related to the vaccine.

NBC:

‘A Boomerang Effect’: Hank Aaron’s Death Is Falsely Linked To Covid Vaccine

The Fulton County Medical Examiner’s office said Monday that Aaron, considered one of the greatest all-around players in baseball history, died of natural causes.

Robert Kennedy Jr. contacted the Fulton County coroner’s office:

Candace, a medical examiner investigator for the Fulton County coroner’s office, told me, “His body was never here. We declined jurisdiction. There was never any autopsy.”

How could journalists not have received confirmation from their source before publishing? And how could they have made such a firm assertion? That the two were unrelated? No one knows if they were related or not.

This post isn’t about whether the vaccine contributed to Aaron’s death. It’s about journalists’ integrity, and lack thereof.

As I said, their is weirdness surrounding these mRNA vaccines.

COVID Vaccine Weirdness

Something weird is going on.

The main stream media is saying that the COVID vaccines:

  • Prevent serious illness.
  • Prevent hospitalizations.
  • Prevent deaths.
  • Reduce transmission.

These are all false statements. As you can see in the table below, the endpoints of the trials, that is, what the trials were designed to detect, were MILD SYMPTOMS. When they say that a vaccine is 95% effective, that means that the vaccine was 95% effective at preventing MILD SYMPTOMS. That’s all anyone can tell from these trials. And the trials are all we have. You can still get infected, you can still transmit that infection, you can still have a serious illness, you can still end up in the hospital, you can still die. No one knows if the vaccine prevents any of those things. What we KNOW is that your symptom of COUGH is less.

The weird thing that is happening is that these false statements are not being flagged as false!

Covid-19 Vaccine Trial Protocols Released, BMJ, 21 October 2020

Contrary to prevailing assumptions (including those of a former Food and Drug Administration commissioner), none of the vaccine trials are designed to detect a significant reduction in hospital admissions, admission to intensive care, or death. Rather than studying severe disease, these mega-trials all set a primary endpoint of symptomatic covid-19 of essentially any severity: a laboratory positive result plus mild symptoms such as cough and fever count as outcome events.

Here’s an example of something in main stream media (Washington Post) that is false:

I’m optimistic that this can happen because of a specific result in the vaccine trials that, so far, has received little attention. Much has been made of the Pfizer and Moderna vaccines being 95 percent efficacious in preventing symptomatic illness. [This is a true statement.] That’s a terrific result, but it’s not the most important one. I’m not so impressed if a vaccine can prevent someone from developing a sore throat or runny nose. I care about whether vaccination means that people won’t become severely ill — to the point that they require hospitalization.

On this front, outcomes from the Pfizer and Moderna trials are extraordinary. … I cannot overemphasize this result: Out of more than 30,000 people who received either the Pfizer or Moderna vaccines, only one person became ill enough to be hospitalized. … This is the end point we should be scrutinizing with other vaccine candidates. [These are false statements. Hospitalization was never an endpoint.]

The fact that there were few hospitalizations in the trials reflects the trials’ designs … they were too small, too short, and did not enlist the very populations that WOULD end up hospitalized, namely older people, sick people, frail people.

Note the “N” in the bottom rows of these charts:

Table 1. Characteristics of ongoing phase III covid-19 vaccine trials


Source: Will Covid-19 Vaccines Save Lives? Current Trials Aren’t Designed To Tell Us, British Medical Journal, 21 October 2020

Not only is what the Washington Post author said verifiably false, but her exhuberance is curious. I feel like she’s gaslighting us.

Why isn’t the Washington Post being criticized for spreading false information?

CDC Issues Report On Vaccine Side Effects Using Data It’s Own Website Said It Shouldn’t Use

The CDC issued a report on an adverse event, anaphylaxis, with the Moderna vaccine:

Allergic Reactions Including Anaphylaxis After Receipt Of The First Dose Of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021, CDC’s Morbidity and Mortality Weekly Report, 22 January 2021

The report used data from CDC’s Vaccine Adverse Event Reporting System (VAERS). The VAERS website says:

It is not possible to use VAERS data to calculate how often an adverse event occurs in a population.

But the CDC calculated anyway:

VAERS detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses administered).

VAERS is good at generating hypotheses but because it underreports it’s not good at calculating rates. The two papers below support this:

Electronic Support for Public Health – Vaccine Adverse Event Reporting System (ESP:VAERS), CDC Grant Report, 2010

Fewer than 1% of vaccine adverse events are reported [to VAERS]. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.

Safety Monitoring In The Vaccine Adverse Event Reporting System (VAERS), Vaccine, July 2015

VAERS data interpreted alone or out of context can lead to erroneous conclusions.

Using VAERS to calculate rates is like, say … out of all the people in the US born with eyes, 7 reported having green eyes … 7 green-eyed people out of 328 million? Or, out of everyone in the state of Pennsylvania licensed to drive a car, 3 reported having an accident in the year 2020 … 3 accidents out of 10 million drivers? You might say that you know more people have green eyes or have had accidents, but that’s not in the database you’re using.

I can understand the drug industry trying to downplay side effects. But it’s the government’s job to counter industry, to regulate them, to stand with the public not the private. That doesn’t seem to be what’s happening here but I don’t know. The only reason I can figure the CDC used VAERS to calculate an adverse event rate is because VAERS underreports. There were other databases they could have used that are more aggressive (“active” instead of “passive”) in documenting vaccine effects. V-safe actually sends messages to your phone, post vaccination, asking “How are you feeling today?” VAERS sits there waiting for people to find it, then take the time and energy to use it.  (After your vaccination, did you or your healthcare worker sign in to VAERS with information about your sore arm or headache?)

These mRNA vaccines (Pfizer/BioNTech and Moderna) have never been on the market. They weren’t tested long enough or with enough people to produce a comprehensive safety profile, let alone reveal long-term effects. Why is the CDC making these vaccines appear safer than what they’re known to be? Where’s CNN on this? The New York Times? Don’t journalists ask these questions anymore?

Trying To Get Vitamin B12 From A Multivitamin Won’t Work

Presence And Formation Of Cobalamin Analogues In Multivitamin-Mineral Pills, The Journal of Clinical Investigation, October 1982

Various vitamins and minerals can “destroy” Cbl* under certain conditions.

In our study, we have shown that the interaction of vitamin C, thiamine, and copper converts CN-Cbl** to a large number of Cbl analogues that appear to contain alterations in the corrin ring.

We conclude that CN-cobalamin can be converted to potentially harmful cobalamin analogues by multivitamin-mineral interactions.

* Cbl = Cobalamin = Vitamin B12
** CN-Cbl = Cyanocobalamin, the type of vitamin B12 often found in multivitamins

Not only does the B12 in multivitamins become unavailable because it forms analogues (“20-90% of the cobalamin was present as cobalamin analogues”), but those compounds it forms can be harmful.

I found this study in Dr. Greger’s video:

Using multivitamins can be inefficient and counterproductive for the supplementation of Cbl [vitamin B12]. The Cbl can be degraded in the presence of vitamin C and copper with the formation of inactive by-products. These compounds can inhibit the transport system interacting with transporter proteins.

What to do? Buy a single-nutrient vitamin B12. Dr. Greger prefers cyanocobalamin because it’s more stable than methylcobalamin. Dr. McDougall prefers methylcobalamin. And either chew it or let it dissolve in your mouth, so it mixes with saliva.

This raises the question of weather you should avoid taking it with vitamin-C-containing foods or beverages … or thiamine or copper. I guess an empty stomach is best.

Vitamin B12 And Depression, Memory

I just tweeted a few studies about how low vitamin B12 levels affect memory and contribute to depression. There are more where those came from.

I don’t think we take B12 deficiency seriously, myself included.

Vitamin B-12 Concentration, Memory Performance, And Hippocampal Structure In Patients With Mild Cognitive Impairment, American Journal of Clinical Nutrition, April 2016

Conclusions: Low Vitamin B12 concentrations within the normal range are associated with poorer memory performance, which is an effect that is partially mediated by the reduced microstructural integrity of the hippocampus.

Vitamin B(12) Deficiency And Depression In Physically Disabled Older Women: Epidemiologic Evidence From The Women’s Health And Aging Study, American Journal of Psychology, May 2000

Conclusions: In community-dwelling older women, metabolically significant vitamin B(12)deficiency is associated with a twofold risk of severe depression.

Vitamin B12 Supplementation In Treating Major Depressive Disorder: A Randomized Controlled Trial, The Open Neurology Journal, November 2013
This study had two groups. Both had depression, both had low vitamin B12 levels, both took antidepressants. One group (73 patients) added B12, the other (39 patients) didn’t.

100% of the B12 treatment group showed at least a 20% reduction in [depression] score. (vs. 69% in controls)

Those at risk of vitamin B12 deficiency:

  • Older adults
  • People with gastrointestinal disorders, such as Crohn’s disease or celiac disease
  • Those who have had gastrointestinal surgeries, such as bariatric surgery or bowel resection surgery
  • People on vegetarian diets
  • People who take metformin (for diabetes)
  • People who take proton pump inhibitors (for heartburn: e.g. Prilosec, Nexium)