Monday, 7 September 2020

Covid-19 and Vitamin D: Randomised controlled trial from Spain

Reina Sofía University Hospital, Córdoba, Spain


At the onset of the pandemic of Covid-19, a number of mainly medical scientists suggested to the government in a variety of ways, direct and indirect, that it would be sensible to use vitamin D supplements to diminish the impact of the virus on the population. Such medical scientists knew of the vital importance of vitamin D in optimising defensive immunity. They emphasised that vitamin D was cheap, safe, and available immediately. It was envisaged to prevent the rapid and often fatal escalation of the infection due to the "cytokine storm", that vitamin D is known to "switch off". 

40,000 deaths, perhaps not inevitable

Unfortunately this advice fell upon deaf ears, and we had to sit and watch while more than 40,000 of our citizens died. Those who understood vitamin D and its common deficiency predicted that those who would be hit the hardest would be the elderly in residential care homes and people with melanin-rich skin, people of black African and Asian ethnicity (BAME). These groups had previously been identified as being at particular risk of serious vitamin D deficiency.

Deaths of 26 doctors

And so it came to pass. 26 working doctors died from Covid-19, and 25 of them had ethnic genetically determined melanin-rich skins. Their  chance of dying in the UK was 20 times greater than in India and Pakistan, and 100 times greater than in equatorial Africa. Vitamin D deficiency was the obvious answer, but it was ignored by the government and its advisors, and also by those responsible for public health policies throughout the UK.

What is proof?

There was a refusal to contemplate giving vitamin D to the citizens of the UK. The reason expressed was that it was "not proven to help in Covid-19 infection". Of course not. Covid-19 was new to medical science and there obviously had not been time to conduct the appropriate trials. For the same reason we do not yet have a tested vaccine. 

Those who expressed this opinion had no understanding of the concept of proof. There were demands for randomised controlled clinical trials (RCTs) before it could be used. It was obvious that this would take a considerable time, and so it has. The first RCT result of vitamin D has now become available, but serious illness and deaths have virtually come to an end in Europe.

Official delays

What has been gained by officially delaying the introduction of vitamin D? Nothing whatsoever. What has been lost? The lives of many people, especially those with melanin-rich skin.

But there has been widespread awareness of the potential value of vitamin D. Word has got around and sales of vitamin D in the UK are thought to have increased by a factor of 30. Perhaps our political leaders and public health officials are taking vitamin D on the quiet. I hope so, but I hope even more that they will spread the message.

Now there is evidence of benefit from Vitamin D that politicians will not be able to deny, but which they might choose to ignore. It has not yet been reported in the UK news media.


RCT from Spain

https://www.sciencedirect.com/science/article/pii/S0960076020302764

So here it is, a review of the the study from the Reina Sofía University Hospital, Córdoba, Spain, which came to my attention on September 3rd.

The study was of 76 consecutive patients admitted to hospital on account of serologically proven Covid-19 infection causing pneumonia as demonstrated on chest X-ray. 

All patients were given on admission hydroxychloroquine and azithromycin (antibiotic), together with general support. They were immediately randomised to receive vitamin D or to act as controls and not receive vitamin D. They were allocated electronically in the ratio of two vitamin D recipients to one control

Vitamin D was given as the liver-activated form 25(OH)D, or calcidiol. To become biologically active it must receive within the immune cells (which it ultimately activates) another hydroxyl group to become 1,25(OH)D, or calcitriol.

The initial dose of vitamin D was 532mcg, which is 20,000 units. A second dose of 266 mcg (10,000 units) was given on days 3 and 7, and then weekly until discharge from hospital.

50 patients received vitamin D, and 26 acted as controls. The two groups were reasonably comparable in respect of prognosis indicators. The outcome measures were the need for ICU admission and death. The decision to admit to ICU would be made without the knowledge of whether or not a patient had been allocated to vitamin D.

Results

Of the 26 control patients, 13 (50%) required admission to the ICU, and 2 died.

Of the 50 patients allocated to receive vitamin D, 1 (2%) needed to be admitted to the ICU, and there were no deaths.


Figure 2. Effect of vitamin D on escalation to ICU support

Diversion to Brazil

A report in the Lancet September 8th is that an RCT of azithromycin (included for all in the Spanish study), which was undertaken in Brazil, showed no benefit from the addition of azithromycin to standard care. Unfortunately vitamin D was not used in the Brazil study and death occurred in 42% and 40% of those given or not given azithromycin. It is a disappointment that the Brazil team chose to investigate azithromycin and not vitamin D.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31862-6/fulltext


Conclusion

It can be concluded from the study from Córdoba, together with very large published data supporting vitamin D, that vitamin D is of immense help in the management of Covid-19 infection, reducing the need for ICU support from 50% of the patients to 2%. 

This study confirmed what was confidently expected and which to many was  glaringly obvious. 

Vitamin D must be taken, ideally well in advance (in other words now) to control Covid-19 infection, to diminish the risk of serious illness and death. This must become official policy. But will it? No doubt sceptics in the ivory tower offices, probably taking vitamin D on the quiet, will demand repeat studies before sanctioning official action.

Ethical considerations

This result of this study was confidently predicted as there has been ample evidence to support the use of vitamin D in optimising defensive immunity at a time of infection. An RCT was not necessary, apart from satisfying the academic sceptics. 

As a result of the result of the RCT in Córdoba, 12 patients needed admission to ICU and two died, when they might not have done had they received vitamin D. 

The 26 controls gave consent when entering the study on admission to hospital. Had they been fully informed of the strong potential benefit of the vitamin D that was, with their "consent", withheld from them? Were they aware of their risk of death (ultimately 8% in this study)? If they were too ill to give consent, were their families informed of these risks? 21 of the 26 control patients were younger than 60 and half of them died. Should their relatives and dependents receive financial compensation for their misfortunes that  resulted from this scientific experiment?

I expect that there will be attempts to rubbish this report, and then demand that the study must be repeated. How many human sacrifices will this necessitate?

Will our medical - scientific - political leaders please come clean and tell us whether or not they are taking vitamin D supplements.



https://www.ypdbooks.com/2147-vitamin-d-deficiency-and-covid-19-its-central-role-in-a-world-pandemic-YPD02419.html



 




7 comments:

  1. I feel that this is very much due to the medical establishment not being keen to accept the views they have always expressed. So similar to the refusal to accept that helicobacter infection was the cause of gastric ulcers all those years ago.

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  2. Dear David: Keep up with the good work and disseminate the factual data and comments on vitamin D and COVID-19.

    Most scientists were disappointed with the premature and unfounded conclusions published by the "National Institute for Health and Care Excellence (NICE) (https://www.nice.org.uk/) and the Scientific Advisory Committee on Nutrition (SACN), UK. Their conclusions are not only mistaken but also failed to account 95% of the published data on this issue in part due to selection biased of studies they considered. Such dogmatic and negative statements indeed can mislead physicians and thus, harm persons/patients through incorrect advice.

    Accumulating evidence is over-whelming, if one cares to evaluate relevant published data (this too is seeming to be somewhat suppressed by filtering research publications by some scientific journals) with an unbiased mind. Based on the trend and hundreds of papers (not necessarily RCTs’ yet), physician who are not advising/guiding their patients with safe sun exposure and/or adequate doses of supplements (or advising too little doses of vitamin D) could be answerable in the future.

    Practicing physicians is expected to provide the” best (and cost-effective) options and advice with least adverse effect” to their patients. In the case with COVID-19, this should be to prevent, recover fast without developing serious COVID-19 related complications or deaths. Currently, adequate doses of oral vitamin D fulfill all these criteria and is capable of rapidly strengthening weaker immune systems allowing patients to recover fast.

    It is unfortunate that excessive and at times, false propaganda by some pharma and by scientific groups with conflicts of interest. The former includes false promises of vaccines and so-called effective anti-viral agents that are more than 1000-fold “expensive than vitamin D” and might have serious adverse effects. Such are misleading the public and government administrators alike. Two recent publications from NICE and SCAN might consider under that category; they failed to consider published data and relied only on a handful of selected (bias) reports making their erroneous conclusions.

    It would be fair for the authorities and politicians to wake-up with a breath of fresh air and ideas, considering highly “cost-effective” means that already available to the public to prevent and treat COVID-19. Such affirmative actions will minimize misleading the public with false propaganda and statistics by various organizations and countries with vested interests though the mainstream news and the social media. Contrary to false beliefs, coronavirus vaccine is not the answer to the current problem.

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  3. I suppose, each one of us MUST make whatever noise we can on a local level to spread this information to every one we can...Facebook twitter whatever. Toxicity, if I remember well, from Vit D is virtually unknown.

    Let's say of each one of us pledge to send this information to 10 of our contacts and each one of them do the same thing, perhaps, we can achieve some level of efficacy.

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  4. Dr. Grimes, I have a question. Obviously azithromycin does not work. Are you aware so far of any report supporting the efficacy (or lack of) of hydroxychloroquine. There are talks about it some for some against.

    There is a report that came from Houston TX about that the combination of Azithromycin and Hydroxychloroquine was effective. Any thoughts on that?

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    Replies
    1. Hydroxychloroquine "switches off" TNF alpha and thereby moderates inflammation. Vitamin D does the same but also switches on immunity.

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  5. Because Summer is virtually over now the only way to significantly raise vitamin D levels is either a lot of oily fish or daily supplementation.

    Sometimes weekly and two weekly supplementation is used. Might work for some.

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  6. There is an RCT registered at the University Hospital at Angers trialling loading doses of cholecalciferol 400,000 and 200.000 iu of Zymad in ampoules. This is used a lot here in France. I found that it was not very effective as if maintenance doses are not taken the vit D level can drop quickly. My doctor prescribed Calcifediol drops daily a few years ago. The original prescription of 4 drops (800iu) gave me a level of 80ng/l after a few months! Doctor said to drop down to 3 drops. On cholecalciferol I could not make it into the normal range on 3000iu a day. I read on vitamin d wiki that Calcidediol is 4/5 times as powerful. I do not think the Angers trial has reported yet. One of the advantages of Calcifediol is that it overcomes any metabolisation issues connected to sub optimal liver function. Given the great results of this pilot trial and the safety of vit D supplementation Calcifediol could be given to all covid patients. What's not to like ? No profits for Pharma.
    On an anecdotal level I sent a spare bottle of my drops to my daughter in London. She and her housemate caught covid back in March. They each took a loading dose of 10 drops then continued with 3 drops a day maintenence. They both reported starting to get better after the loading dose. This is a much smaller dose than used in the Cordoba trial but they are young and fit.

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