Vitamin D

Vitamin D has been incorrectly classed as a vitamin since it was discovered in the 1920s and ’30s. It is in fact an important hormone precursor that regulates the synthesis of many other hormones. Vitamin D is necessary for strong bones; it regulates calcium absorption and helps direct it into bones and teeth. It is an all-rounder that not only influences physical performance, helps build bone tissue and sex hormones, affects the immune system and mood, but also plays a significant role in treating cancer and cardiovascular diseases and in pregnancy.

Vitamin D exists in two forms: cholecalciferol (a biologically inactive form that is produced in the skin with the help of sunlight) and calcitriol (a bioactive form that is converted from the inactive form in the liver and kidneys with the help of enzymes). Recent research has shown that many organs, such as the brain, the skin and the immune system, are capable of producing their own active vitamin D if necessary. But the vitamin D cycle is highly complex and is regulated by a number of different factors. Even leading researchers like Dr Michael Holick are of the opinion that no more than 25% of the effects of vitamin D have been discovered and understood so far.

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Vitamin D and autoimmune diseases

Dr Coimbra developed the theory of “individual vitamin D resistance” (the medical community has long known about vitamin D resistance in rickets) because the required daily dose varied significantly between his patients. It has now been shown that vitamin D resistance can have a genetic cause. Variations in individual DNA segments disrupt the production, conversion or utilisation of vitamin D.

In order to overcome this genetic resistance, known as a single-nucleotide polymorphism, some people need incredibly high daily doses of vitamin D. This reactivates vitamin D metabolism and enzymatic processes at cell level. As soon as sufficient active vitamin D (calcitriol) arrives in the cell, the immune system stabilises again: the autoimmune reaction is halted, while the natural immune defence against pathogens is strengthened. As long as the patient produces enough calcitriol, the immune system works perfectly.

Dr Coimbra explains that people can develop an autoimmune disease if at least three factors are present:

• genetic vitamin D resistance
• leading to vitamin D deficiency
• stress or emotional strain

This explains why a vitamin D dosage that is sufficiently high for the individual can stop autoimmune diseases and even stimulate healing of damaged tissue to a certain extent.

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Treatment pathway

Before treatment starts, comprehensive lab tests are requested to make sure that the patient’s basic underlying health is good, particularly in the area of the thyroid, parathyroid and kidneys. In addition, the basic blood values are used to adjust the individual vitamin D dose later on. The precise list of tests required varies depending on the type and duration of the disease and is sent by the doctor once an appointment has been made for an initial consultation.

Once the results of the basic tests are in, the patient has an initial consultation with the certified protocol doctor. This is where the treatment is explained in detail and any necessary lifestyle and dietary changes are discussed.

This practical part of the consultation is often carried out by trained patient advisers. Following a full medical history and examination, based on the blood work and the type and manifestation of the disease, and on individual parameters such as weight, height, etc., the doctor will prescribe a starting dose of vitamin D. This dose cannot usually stop the progression of the autoimmune disease, but it is a safe starting dose from which to work towards the effective individual vitamin D dose. In the case of very aggressive disease, an acute episode and/or the risk of permanent damage, such as blindness or other disabilities, the doctor may start with a very high dose. More frequent check-ups may be needed in these cases.

Normally, a patient will need 4 to 6 appointments with the trained protocol doctor at 3-month intervals to start with, then every 6 months and, from the third year onwards, only annual check-ups. Recent blood and urine results are required for the check-ups.

These check-up appointments have two objectives:

• To ensure the safety of the patient. If unusual metabolic changes occur, the doctor is able to spot them in good time and correct them before symptoms appear.
• To find the correct individual dose to ensure maximum effect and bring about remission as quickly as possible.

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Cofactors

Most of the Coimbra Protocol effect is achieved by rebalancing the genetic vitamin D resistance described above. Other cofactors are needed to ensure that the vitamin D is converted into its hormonally active form. The most important of these are magnesium and various B vitamins, especially vitamin B2.

To reduce inflammation processes, stabilise normal immune function and optimise cell metabolism, therapeutically effective high doses of other dietary supplements are used with the Coimbra Protocol (depending on the severity of the disease). These are omega-3 fatty acids with high levels of DHA and EPA, chromium, zinc, selenium and choline.

A substance-free but no less important cofactor involves regulating the stress response in the brain and hormonal system. Patients are informed by their doctors about the impacts of stress on the immune system and are given suggestions on how to achieve mental balance. Psychotherapy to process traumatic experiences is often recommended.

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Necessary dietary & lifestyle adaptations

As well as generally eating healthily, the following measures are a vital part of the Coimbra Protocol:

• Reduced calcium intake: avoiding dairy products, reducing nuts and seeds, no green smoothies
• Drinking at least 2.5 litres of fluid per day: ideally low-calcium water, unsweetened tea or a mixture of fresh fruit juice and sparkling water
• Exercise: at least 30 minutes of light endurance exercise, such as walking briskly, using a vibration plate or bouncing on a mini trampoline, or strength training, 3 to 5 times per week
• Stress prevention / ability to self-soothe, e.g. through meditation and psychotherapy, where relevant

Diet is often an area of uncertainty, especially among patients with an autoimmune disease. The question “What is a healthy diet?” is difficult to answer and regularly leads to disagreements.

According to our research, there are a few cornerstones of a healthy diet on which different schools of thought agree:

• Eat fresh, unprocessed produce where possible
• Avoid artificial additives (these can be an extra irritant to the immune system)
• Limit alcohol – preferably wine or beer rather than hard spirits
• Plenty of micronutrients => lots of fresh fruit and vegetables
• Reduce/avoid simple carbohydrates like sugar and white flour, since these have been shown to have an inflammatory effect
• Give priority to plant, animal and fish products from organic, sustainable farming to minimise traces of pesticides, antibiotics and heavy metals
• Drink plenty of fluids, where possible clean, uncontaminated water

There is also a relatively large body of evidence for avoiding animal dairy products altogether. Numerous studies have shown that dairy products can have an impact on hormones in the body, which can increase inflammation. In addition, a large proportion of the world’s population (Northern Europe 15%, Africa and Asia around 95%) are lactose intolerant from puberty onwards. Since the Coimbra Protocol requires a reduction in foods containing calcium, avoiding animal dairy products is recommended.

Moreover, when it comes to diet, increasing numbers of people are concerned about the evident negative impacts of animal products on the environment and the climate, especially those from intensive livestock farming. Compassion for the animals with whom we share the planet is also leading some people to switch to a vegetarian diet. However, Dr Coimbra and many other researchers believe that a purely vegan diet is unhelpful for patients with autoimmune diseases such as multiple sclerosis. Since the myelin sheaths, the brain and the nerves consist primarily of protein and animal fats, it is advisable to include at least a small amount of animal protein in the diet to maintain and restore them. Our bone metabolism and muscles also need a balanced supply of amino acids to work properly. Likewise, certain B vitamins are only found in animal products. A purely vegan diet has to be planned very carefully to make sure it is balanced, and may need to be supplemented with amino acid preparations and extra vitamins to ensure optimal healing under the Coimbra Protocol.

There have been several studies showing a positive impact of a ketogenic (keto) diet in neurological and autoimmune diseases. Keto diets typically consist of a high proportion of fat, a balanced amount of animal protein and very low levels of carbohydrate. This resets the body’s metabolism, causing it to burn fats as its main fuel, instead of carbohydrates. In this diet, the liver produces ketones (or ketone bodies), which, among other things, have an anti-inflammatory effect, stabilise brain metabolism and activate the burning of excess body fat. Some Coimbra Protocol patients have chosen this type of diet and report above all increased energy, greater mental clarity and better sleep.

However, the Coimbra Protocol is not a dietary intervention like the Wahls diet or the Autoimmune Protocol. The only mandatory requirement is to reduce calcium intake. It is not necessary to avoid gluten, nightshade vegetables, linoleic acid, or other food types. However, patients with known food allergies should avoid the identified allergens. Dr Coimbra has observed that after the right individual vitamin D dose has been found and remission achieved, food intolerances and allergies often disappear too.

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What is the purpose of these measures?

Without switching to a low-calcium diet, prolonged administration of high doses of vitamin D can lead to hypercalcaemia (excess calcium in the blood and urine), which can damage the kidneys in the long term. A low-calcium diet and drinking plenty of fluids are a double safety net against hypercalcaemia. In addition, in the first year of treatment in particular, the patient’s blood and urine values are kept under close observation by the protocol doctor.

Without sufficient exercise, prolonged increased bone metabolism can lead to earlier osteoporosis. The good news is that sufficient exercise is often found to improve bone density in patients. Regular exercise, preferably involving impact and push and pull on the bones, activates bone metabolism. Exercise is by far the best way of maintaining bone density. In addition, it activates the formation and maintenance of nerve and brain structures and breaks down stress hormones, which reduces inflammation.

In order to spot any decline in bone density during treatment promptly and to take countermeasures, bone density scans (known as DEXA scans) are requested at the beginning of treatment and then every year or every two years. If a patient is found to be losing bone mass too fast at a young age, because of long-term cortisone therapy or a rare genetic disposition, the protocol doctor can intervene in good time with additional dietary supplements and, as a last resort, with medication.

Stress prevention, which is strongly recommended, serves to prevent the immune system going into overdrive as a result of stress hormones. If we feel a situation is overwhelming and something we cannot cope with, it leads to the secretion of stress hormones, which automatically increases inflammation values in the blood and brain and leads to overactivation of the immune system. If the patient is not yet firmly established on their optimum vitamin D dose, i.e. not yet in remission, stress can cause a flare-up of the autoimmune disease. This effect has been demonstrated in numerous studies. However, there are many publications demonstrating the positive impact of relaxation exercises and/or mindfulness meditation on reducing stress hormones, inflammation and autoimmune disease relapses.

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Treatment effect and objectives

As a result of improvements in cell and brain metabolism and detoxification, most patients already see a remission of inflammation in the first few months of treatment. They have more energy, and depressive moods and insomnia improve.

Once the individual vitamin D dosage has been reached, optimum regulation of the immune system starts: autoimmune diseases enter remission, in most cases permanently. No new flare-ups or symptoms appear and no increased inflammatory activity can be detected through imaging or in blood tests. In relapsing-remitting diseases, this status is generally achieved 6 to 12 months after treatment starts. Long-term patients with progressive diseases need to allow at least 12 to 24 months of treatment before remission is achieved.

Experience with this kind of treatment now includes patients who have been treated for up to 15 years. Dr Coimbra assumes that patients with autoimmune diseases will need to continue taking a high dose of vitamin D and other cofactors throughout their lives to stay in remission. However, it is often possible to reduce the daily dose somewhat after 1 to 2 years if the metabolism has obviously improved. It is still unclear whether long-term treatment could potentially cause the immune system to “forget” the incorrect information that causes it to attack the body’s own tissue.

There is a also a chance, in the long term, that more recent tissue damage can be healed: vitamin D stimulates the formation of new skin, brain and nerve cells. Researchers, including a team at the University of Cambridge in 2014, have demonstrated in animal experiments that high doses of vitamin D lead to regeneration of the myelin sheath that protects the nerves. This means that even patients with brain or spinal cord damage caused by multiple sclerosis gradually experience a reversal of more recent symptoms, especially if they occurred in the 12 to 24 months before starting treatment. Younger patients who have been ill for less time generally experience a complete remission of symptoms and can go on to lead a normal healthy life.

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Side effects

When administered correctly and under medical supervision, no side effects are to be expected. However, since the idea is to correct hormone metabolism, mild symptoms and hormonal fluctuations may be experienced in the initial phase, e.g. changes to the menstrual cycle.

The only potential side effect is linked to changes in the amount of calcium absorbed from food. High doses of vitamin D cause all the calcium present in the gut to be absorbed into the blood. Normally, calcium absorption is restricted by hormone feedback loops. But since these are deactivated in the Coimbra Protocol, there is a theoretical risk of vitamin D toxicity (hypercalcaemia), which, depending on severity and duration, can damage the kidneys. To prevent this, it is vital that patients are supervised by a certified doctor (a “protocol doctor”) and that they stick to a low-calcium diet and drink sufficient fluids.

If these measures are followed, the treatment is safe and free from side effects. Since the therapy was introduced in 2002, no patients have suffered permanent harm. Fewer than 1% of all patients treated suffered temporarily from critical blood values, and most of these were caused by dietary errors.

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Initial consultation with patient adviser

For the Coimbra Protocol treatment to be safe and successful, a few lifestyle and dietary changes are necessary. Patients must be willing and able to stick to these, otherwise treatment is not possible.

Don’t worry though: the reasons for these adjustments and practical tips for sticking to them will be explained in detail during your initial consultation. Some protocol doctors work with our founders, Christina Kiening and Britta Maier-Peveling, in their role as therapists and health advisers. Their explanations are easy to understand and practical, and they share their the experience they have amassed over many years as patients themselves. Besides their in-depth knowledge of the Coimbra Protocol, both women have completed health-related training, e.g. in nutrition counselling, exercise therapy and psychotherapy, and have been offering accompanying therapies for chronically sick patients for many years. Since the hourly fees for patient advisers are lower than standard doctors’ fees, this collaboration also lowers the costs for patients.

And if you are still unsure whether this treatment is right for you, you can book a preliminary personal information session with a patient adviser by telephone or Skype.

To book an appointment, please send an email to:
Christina.Kiening@coimbraprotokoll.de or Britta.Maier-Peveling@coimbraprotokoll.de

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Costs

Legally, the Coimbra Protocol treatment is classed as an as yet scientifically unproven experimental alternative therapy. This means that the costs are not covered by statutory health insurance schemes. Supplementary insurance schemes for private alternative therapies will reimburse some of the costs.
The following is a rough estimate of the costs:

• Private doctor’s fees, generally €200 to €300 per hour.
  These vary depending on the region, and whether the doctor is a specialist or professor, and on the doctor’s experience. The length of appointments also varies considerably: the first appointment lasts approximately 1.5 to 3 hours because there is a legal requirement for comprehensive explanations and documentation. In order to reduce the costs for patients and to provide practical explanations, some protocol doctors work with trained patient advisers. The follow-up appointments are usually much shorter and therefore cheaper.
• Laboratory costs, approx. €85 to €250 per analysis.
  These vary considerably depending on the number of blood and urine values required, the type of the disease, comorbidities and the laboratory chosen. Please ask the doctor in advance which lab results are necessary, which are recommended and why/whether a particular laboratory is recommended.
• Dietary supplements, approx. €120 to €200 per month.
  The costs vary depending on the selection of preparations and where they are sourced from. We strongly recommend focusing on quality and the absence of bulking agents and auxiliary substances, where possible. Some doctors sell their own dietary supplements, which may be of a high quality but are usually much more expensive than buying quality-tested products online. We have compiled a list of product recommendations, including the preparations that we use ourselves.
• Additional examinations: Depending on the underlying disease and any comorbidities, additional investigations may be necessary (e.g. full immunologic blood work for rheumatic diseases or an MRT for multiple sclerosis).
• Generally, a bone density scan (DEXA scan) will be requested before starting treatment, and then once a year for monitoring purposes. This is because the permanent inflammation activity associated with autoimmune diseases and cortisone, which is frequently administered to treat them, combined with years of vitamin D deficiency and a lack of exercise due to illness can contribute to a loss of bone density.
• A comprehensive preliminary test of kidney function, including an ultrasound scan to rule out kidney stones, is also recommended before starting treatment and once a year from then on.

It is worth asking your specialist or family doctor whether some of the necessary tests can be ordered on prescription and covered by the statutory health insurance schemes.

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Legal framework

Orthomolecular treatment of autoimmune diseases using individual ultra-high doses of vitamin D is not yet scientifically recognised. This means that the doctor must comply strictly with the legal regulations for experimental therapies issued by the World Medical Association (WMA). The legal framework is set out in § 37 of the WMA Declaration of Helsinki and is intended primarily to ensure the safety of patients. Among other things, it requires that patients are fully informed of the basic principles of the therapy, the expected successes and potential risks, and also requires comprehensive documentation. After being fully informed, patients are usually asked by the doctor to sign an agreement stating that they undertake the treatment at their own request and at their own risk.

Since ultra-high-dose vitamin D therapy can lead to serious kidney damage if administered incorrectly, we strongly advise against starting this treatment without the supervision of a suitably trained and certified doctor.

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