Vitamin D therapy reduces Covid fatalities. Time for a VitD trial.Results in 4 weeks.

[Bettertobehealthy]

Following my earlier posts here on Mumsnet regarding the use of Vitamin D3 and beneficial effects against Covid. A new Lancet paper (Pre-print of study) of 20th Oct papers.ssrn.com/sol3/papers.cfm?abstract_id=3690902

It states: ' Treatment with vitamin D, regardless of baseline serum vitamin D levels, appears to be associated with a reduced risk of mortality in acute in-patients admitted with Covid-19 '

 This is a further indication that we are missing a great opportunity to cut our death rates and severity of illness when infected.   The retrospective study was carried out on the data of over 900 hospitalised patients from Leicester, Tameside and Preston hospital trusts.  Treatments with Vitamin D were either 800 IU -2000 IU   i.e maintenance doses, or  bolus doses of up to 300,000 IU  i.e. shots  

I have been proposing a trial be carried out, of Vitamin D3  loading doses for people that have just been diagnosed, i.e. hopefully at an early stage of illness prior to hospitalisation. The dose levels are perfectly safe for the overwhelming majority.  

The data from a pilot study in Spain (Cordoba Hospital)    <a class="break-all" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456194/" rel="nofollow" target="_blank">www.ncbi.nlm.nih.gov/pmc/articles/PMC7456194/</a> 
which used a Vitamin D derivative,  532 microgram doses of 25hydroxyD3 (i.e.  calciferol, or calcidiol) showed remarkable results.  A 25 fold reduction in patients requiring ICU after admission to hospital, when treated with 25hydroxyD3.   We can try to replicate that success using cholecalciferol ( Vit D3 supplement) ,  available  on the high street, online  etc etc.    By using daily doses of 10,000 IU   (250 microgram)  for 14 days upon diagnosis. Followed by  5000 IU daily for another 14 days .       At the end of this 28 day period , we should see a marked difference in outcomes between treated and untreated Covid positive people.  The two studies mentioned above should give us great hope, that this idea is correct.   Cholecalciferol is rapidly converted in the liver to  25hydroxyD3 (calciferol, ie. calcidiol) .  The half life of cholecalciferol is 24 hrs in the blood. 

  About a month ago I posted a more detailed explanation of this suggested trial here   in "general health".    <a class="break-all" href="https://www.mumsnet.com/Talk/general_health/4039300-A-Strategy-to-Limit-deaths-Caused-by-Covid19-Using-Vitamin-D-Therapy" target="_blank">www.mumsnet.com/Talk/general_health/4039300-A-Strategy-to-Limit-deaths-Caused-by-Covid19-Using-Vitamin-D-Therapy</a> 
            I have been trying to  interest  the health service/gov / parliament/  even media outlets to try and get this trial instigated.  The cost of the trial would be less that the cost of treating just one person that has complications from a stay in ICU. The contact data of Covid positive tested people would be required So the gov. needs to agree. Results should start to be known within 4 weeks.  The trial would involve sending  28 days worth of doses of VitD3  ( total cost £2 per person )  to  a selected sample of  Covid positive people, then, phoning the treated and untreated on a weekly basis, to establish whether they were still at home isolating or  hospitalised, or sent to ICU, or passed away.  The sample of people would be chosen to avoid those rare individuals with hypercalcaemic conditions  or possible contra-indications  such as  those on treatment with digoxin.  Selecting older individuals, such as over 50's, would give quicker results.     

 IF any readers here, can add their input to getting such a  trial done, maybe forward this idea to perhaps some official body, media outlet etc,  then please do. 
         Within a few weeks this could well give this country a way to cut many deaths, prevent ICU's being filled , reduce the need for lockdowns and reduce hospitalisations. At a cost that is insignificant when compared to the potential benefit.  We should start this trial immediately, there is nothing to lose and everything to gain. 
As a private individual, retired, I have no financial interest in VitD . I have  posted quite a bit about the physiology of VitD here on Mumsnet, over quite a number of years. 

Here is a thread where I posted quite a bit of detail about Vit D , and why we need it, why we are mostly too low, and what we can do about it. It is a long read , but might be helpful to some.
www.mumsnet.com/Talk/general_health/2841497-If-you-are-vitamin-D-deficient-what-have-you-been-prescribed

Best of luck to all
BTBH.
.

Great post

Thanks for this @Bettertobehealthy, amazing work. I’ve been wondering this all along. Why is more not being done in this area?

I’ve chatted to you on other threads about Vitamin D. I was part of a study on vitamin D and breast cancer outcomes. So I’m quite passionate about this.

Surely the evidence regarding Vitamin D and COVID outcomes is there to see. On a personal level I am telling friends and family to keep their levels topped up through the winter.

Very interesting
I think that bame communities have higher rates of mortality /hospitalisation due to low vit D
I don’t know why it’s not mentioned as a possible cause.

@Bettertobehealthy I've also had quite strong feelings/thoughts about vitamin D being linked to outcomes. Lots of groups deemed higher risk quite often have lower vit D levels - BAME, BMI over 40, elderly, health care professionals....

Out of interest how much would you recommend for individuals to take daily?
Any Extra for groups listed above?

Thanks so much

I read that there an ethical challenge with doing vitamin D research? You can’t ethically test everyone for their vitamin d levels and then have a “control group” that isn’t given supplements it they’re found to be deficient.

Do you know if there’s any benefit for people with long covid?
Lots of help needed in this area now 💓

Bump

I admire your tenacity and passion @Bettertobehealthy!

Have you seen the QMUL CORONAVIT clinical trial that is investigating whether vitamin D can protect against COVID-19?

www.qmul.ac.uk/media/news/2020/smd/clinical-trial-to-investigate-whether-vitamin-d-protects-against-covid-19.html

You might be interested in looking through the current ongoing worldwide clinical trials into vitamin D and treatment/prevention of COVID-19.

clinicaltrials.gov/ct2/results?cond=Covid19&term=vitamin+d&type=&rslt=&age_v=&gndr=&intr=&titles=&outc=&spons=&lead=&id=&cntry=&state=&city=&dist=&locn=&rsub=&strd_s=&strd_e=&prcd_s=&prcd_e=&sfpd_s=&sfpd_e=&rfpd_s=&rfpd_e=&lupd_s=&lupd_e=&sort=

@Redolent , re ethics, you are right, lawyers would have to sort it out. BUT,
about 500 people per day are dying. My suggestion is to offer this trial therapy, immediately that, say, a person over 50, is found to be positive. There is no time to have blood tests. We are relying upon the liver to convert cholecalciferol to calciferol, so we need to give it to those positively tested very quickly. If it was legally required, then we could give the option of say 400 IU , (10 microgram ), to those unwilling or not taking the trial loading dose of 250 microgram daily. Some people will already be taking a multi-vit ( usually containing 5 or 10 mcg VitD). Some even higher doses. It would be necessary to find out each individuals dose requirement, depending upon their current intake. However, a total loading dose of 210,000 IU over 28 days is not harmful to the great great majority of people, especially when you consider how Covid might affect them. The human body can make 10,000 IU or more of vitamin D in less than 1 hour sunbathing. This trial is equivalent to a short sunbathing session , every day for 21 days. ( from the Vit D repletion point of view. )

BTBH

[quote raeray]@Bettertobehealthy I've also had quite strong feelings/thoughts about vitamin D being linked to outcomes. Lots of groups deemed higher risk quite often have lower vit D levels - BAME, BMI over 40, elderly, health care professionals....

Out of interest how much would you recommend for individuals to take daily?
Any Extra for groups listed above?

Thanks so much [/quote]
I would suggest you get your vitamin D levels tested, if you are concerned @raeray

Here are the current NHS/PHE guidelines on taking vitamin D supplements:

www.nhs.uk/conditions/vitamins-and-minerals/vitamin-d/

Too much vitamin D can be harmful but if you have a deficiency, you might be prescribed a higher dose than the recommended maximum daily intake so it is better to get tested.

Really good thread. Very important.

This is a good explanation of

This is a good explanation of the process of setting up clinical trials:

www.ncbi.nlm.nih.gov/pmc/articles/PMC1997262/

@orangenasturtium , thanks, and thanks for the links.
Yes , I have seen the Queen Mary CORONAVIT trial. It reports in 9 months. That trial is about finding if small VitaminD doses will help prevent Covid ... i.e supplementation. The trial I am suggesting is different ... it is testing a treatment, i.e. a loading dose, to see if we can replicate the Spanish trial mentioned above. IF this trial works we will know in 4 weeks. We can start within a week. Given that the gov. pulls its finger out. It takes, motivation and resources. We are in the worse situation since the war, I would hope they might take this seriously. All it would take is a dozen or so admin people, a large office, internet and phones and computers for them. Oh ... and maybe a lawyer or two. Also flow of contact data for the people we need to join the trial, from a track and trace office. And a supply of Vit D , costing about £2 per volunteer.

Just to reiterate , the Spanish trial :   of 50 people treated with calcidiol only 2% needed ICU and none died. OF the untreated with ( calcidiol)  50% needed ICU  and `8% died.  A result , anything like that would transform this country's response to Covid. Saving many lives. 

BTBH

You asked for input about getting this trial done, so this is my input - this is the area I work in.

Unfortunately there is a lot more to setting up a trial, however worthy it may be. I am not saying the following to dampen your enthusiasm but it is the reality.

The contact data of Covid positive tested people would be required so the gov. needs to agree
The government itself would not agree, a Research Ethics Committee would approve how potential participants are identified and approached.

Within a few weeks this could well give this country a way to cut many deaths, prevent ICU's being filled , reduce the need for lockdowns and reduce hospitalisations
Back of the envelope calculation, to start from scratch starting a trial like this (meaning first person in the trial starting treatment) would be 3 months earliest. This includes all the time savings with fast track processes we currently have for covid research in the UK.

Results should start to be known within 4 weeks
This is not realistic. Just the process of collecting the data in a way that it can be analysed would take at least this long.

The trial would involve sending 28 days worth of doses of VitD3 ( total cost £2 per person ) to a selected sample of Covid positive people
How many people? The statisticians would have to work this out first. And you can’t just identify a set of positive patients, send them the vitamins and tell them to take it and that you’ll be in touch to collect data. They have to agree to do this and give written consent. One of the biggest delays in medical research is the time to identify enough of the right people (in this case covid positive people) who are willing to take part. Never ever underestimate how difficult this is. You think it is a great idea, you can’t understand why anyone would object. But they will.

The sample of people would be chosen to avoid those rare individuals with hypercalcaemic conditions
But you have said there is no time to do blood tests. If you agree it is dangerous to give vitamin d to hypercalcaemic people I doubt you would get ethical approval to do this with no testing and they would require you to do this to identify anyone with undiagnosed conditions.

re ethics, you are right, lawyers would have to sort it out
The question of ethics is not settled by lawyers but by a national research ethics committee who must approve all trials of this nature.

These are just a few specific points from what you have written to try and help show why it really isn’t as straightforward as it may seem. Medical research is highly regulated, with an ethical framework that has been developed over many decades. It is no doubt overly bureaucratic in many ways but the fundamental principles cannot be cut and would mean there is way more to doing this.

I haven’t looked at orangenasturtium‘s links but hopefully they cover what you have proposed - no doubt the quickest way to get answers is to find someone is already doing it

Everyone should be taking vitamin d in the winter in the uk. You can't generate enough without supplements this time of year. I suffer with ms and take a high dose that has been proven to reduce some of the issues with ms. It definitely helps with so many things.

@How2Help ,

                            ok , thanks for your help.  I guess I should just shut up and recognise that the situation is not serious enough to merit  just getting on with it. Only 500 people per day are dying. The country is falling apart, millions will lose their jobs. We would not want to break any bureaucratic procedures.   Sorry, just being facetious...    I recognise that you are being helpful.  At least I know what objections will be raised. I appreciate that.  

                           Here is another way of looking at it.   Vitamin D is a nutrient. It is found in food.  Would we need all those bureaucratic procedures if  we were testing, lets say, does an apple a day, help with reflux?    OR    lets say, akin to Captain Cook.  He had heard that citrus might help with scurvy. When sailing ships were on long trips nearly everyone came down with scurvy. Many died.  On the way to Australia, he gave his men citrus. They stopped dying.   He had found an answer. Nobody could argue with it. The effect of his 'treatment' was so stark.          Did you read the result of that Spanish trial.  ?  A 25-fold diminution in ICU admissions when treated with calcidiol.  When untreated 1 in 13 patients died, but  when treated none died. 
 
         We 'know' a great deal  about  VitD,  we would be giving volunteers the option of  a daily sunbathe ( in tablet form ).  A food supplement. 

With regards to hypercalcaemia. That is a longterm condition, it is so rare due to Vit D overdose, that it should not be worried about. In the medical literature it has never been seen at doses below 30,000 IU per day, long term. A covid infection is so much more serious in the short term than the possible effects of hypercalcaemia in the long term. In any case, as soon as recovery from Covid is achieved, the dose of Vit D can be dropped if necessary. It is a matter of risk. An expert endocrinologist would concur with me. We would ask our participants , ... do you have hyperparathyroidism? , do you have any granulomatous disease?, do you have Williams syndrome , etc. IF the answer is No, then the chance of becoming hypercalcaemic from VitD within 28 days is infinitesimal. Even if a person did, the benefit of fighting covid could far outweigh a few days of higher blood calcium. Again, consult an endocrinologist.

IF this trial is commenced quickly , then the results will start to come in within 4 weeks of starting.      In other words we will see if it is working.   I did not mean  all the data will be in, and the final report written.  IF we can treat say 500  in the first week, then 4 weeks later , we will see differences arising- hopefully-  in the outcomes of the treated and untreated, assuming the results are similar to the Spanish trial.  Those results will inform our doctors of what might be a good treatment of the 30,000 daily cases we will probably see by then. We know that Vitamin D is very safe, a medical judgement will need to be taken.    That is the essence of medicine,  the doctor makes a judgement of what is best for his patient, based on the best evidence he has to hand. 

 As regards to the number of people. My answer would be a few thousand. Since we don't know the results of the trial,  we don't know how many people we need in the trial to reach a 95% confidence level. We keep going until we see the results. The statisticians work on the numbers that come in day by day.  IF the results are as stark as we hope, then it would not take longer than 4 -6 weeks to get a result. We could then improve the study by varying  the dosage level, to maximise recovery.  

  I recognise that this approach is not  how things are normally done. Yes it would be very good to follow all procedures,  in a year or two we would probably have some answers. By then thousands will have died, and the economy might be in ruins.  On the flip side, if we ask volunteers to try a food supplement, that millions of people have been taking, worldwide for many years, then we might improve our situation mightily. 

               I know what I would choose.  But it is not up to me ... it is up to  the government. 

              Just out of interest ...  <strong>How2Help</strong>  if this trial was done with volunteers, outside of government  ... would that be feasible. ? legal ? 

                   Thanks very much for your contribution, sorry for the facetious comments above , not aimed at you  but the whole situation we find ourselves in. We have to do something about it, not just sit around and twiddle our thumbs. ! or wait for somebody else to do something. 

             The UK is a high latitude country , with Vitamin D blood levels dropping from now until next April,  when the sun again goes above 45 degree elevation , and we can again start to create Vitamin D in our skin.  It is a sad fact that Covid cases will likely be affected more and more severely until mid April, without intervention. 

   best of luck all  

                 BTBH

@How2Help clearly has experience in this area and shouldn’t be derided or scorned for pointing out simple facts in a rationale manner.

Have just briefly read the Spanish study. They had patients randomised to receive Vit D, but all patients were also being given hydroxychloroquine and azithromycin. (The authors admit themselves that there is now no good evidence did using hydroxychloroquine against COVID-19). In the UK, patients do not get these prescribed as baseline treatment for COVID which is one reason why these results cannot be extrapolated to work for our population. Moreover, the baseline characteristics of two patient groups vary somewhat with patients with underlying hypertension and diabetes in the ‘no Vit D’ arm. Meaning there is a bias there.

Speaking as an ICU doctor here. There are not many studies that have actually changed our practice in the last 10-20 years unfortunately. There are some therapeutics that I would love to have evidence that they work because theoretically and physiologically, they should!

Research is humbling, and takes a great deal of patience.

Such a shame that something that could have a profound effect on the death rate can’t be implemented due to red tape. Speed is of essence when 500 people a day are dying and we may have the answer (to save even a few if these is worth it) in a vitamin/hormone that is cheap and readily available. Weren’t they experimenting with high doses of vitamin C in New York? Maybe it’s not a trial that is needed (not enough time). But an instruction from the government to just dose up ICU patients? If we know there is no harm in a loading dose for a week.

How2Help wrote a good post

The Ling et al group also registered a case-control study too that has yet to report. There are limitations in the sample of convenience study they reported on so far (OP's first link above).

I guess I should just shut up

OP, you wrote that because you think you already know the answer.
You won't accept any result that doesn't confirm what you already believe. This is pants and absolutely the wrong way to do science. You're coming across as dogmatic & arrogant. I've lost sympathy with your cause when it's clear you'll keep "campaigning" for the only result you would see as valid. That's why you're happy to cut corners and do research your way. Because you have an agenda rather than want to find good quality evidence about the question.

If you want to influence people to run your experiment then raise money to fund the trial. You'll need a cool £100k is all, I reckon, which is cheap as chips for a good RCT. You've been ranting about this for months so wasted a lot of fund-raising time already. HCPs, Epidemiologists and public health officials are already volunteering lots of their time to covid response. Don't demand more unpaid time for your pet cause.

Yet dismissed flippantly, arrogantly and untruthfully by Matt Hancock in the Commons.

It’s been obvious for decades that Vit D is a fundamental defence for respiratory diseases. Flu mortality is also linked to vitamin D deficiency - just look at the way the flu season operates. It’s not a coincidence

Anyway, pathetic that they govt lied and dismissed this. Deathly even.

This video gives a very good summary of all the research around Vit D

It’s pre COVID

OP, thank you for this. I'm frustrated that a high dose isn't being given on admission to hospital for Covid as standard treatment. With a follow up lower dose 2-4 days later as per the Spanish trial. Vitamin D isn't a controversial new drug. It isn't dangerous. It is already known that it supports the immune response. There is no downside to giving it. It shouldn't require a clinical trial.
We can assume the patients in the Spanish trial had excellent ICU care, because 11 out of 13 patients were discharged and only 2 died. But with only 2% of the vitamin D hospitalisation needing ICU and no deaths at all, it's batshit that the UK hasn't trialled this or implemented it as treatment already.
The drugs given in Spain as their standard hospital treatment back then, haven't been particularly successful in trials. Vitamin D was the differentiator.
I wish I could help promote this. Very frustrated that we're looking at another 40,000 deaths perhaps which could be prevented easily. Not to mention getting the economy and everyday life back on track. Are we having this lockdown because the government has turned a blind eye to 2p treatment?
By the way, vitamins (with clear instructions on the higher dose required) could be given at walk-in/drive in test centres, so it may not even be necessary to send them to homes.
GPs could prescribe to everyone shielding and in care homes. The population can usually afford this supplement easily themselves.

I've written about vitamin D on mumsnet too - and elsewhere on social media. It's about all we can do. Anyone who finds out about this after a relative dies could sue their doctor for not dosing them with vitamin D but the case would not succeed - yet. But intervention trials are underway in other countries and we may get to the point where a civil case would be possible.

Personally I already regard it as unethical for doctors not to treat with vitamin D. However doctors who did this could find they faced disciplinary action so few would risk it.

This is one time when I believe conspiracy theories are justified. The reason we do not have an intervention trial in place is that drug companies can not make money from vitamin D. If it was as successful as the studies suggest (and I accept all the caveats as to why it might not be) then the drug companies would make less profit from selling governments other products. We have a prevention trial only because there was enough public knowledge for the government to have to do something so go for the one least likely to be effective and placate the drug companies as well as ensuring results are slow.

Your best bet is to kick up enough of a public fuss to force the government to take action but good luck with getting newspapers to cover it.