It was a few months before Ana Claudia Domene's 40th birthday when she woke up one morning with a strange tingling sensation in her feet. She must have exercised too much the day before, she thought, but as the day wore on the tingling spread up her calves and into her thighs.
By the time Domene finished work, it was like she was wearing an electrical body suit up to her neck. "My whole body tingled for an entire month," she recalls. "I lost control of my right arm so I couldn't even hold a blow-dryer in my hand, my left leg became weak, but the extreme fatigue was really terrible."
She remembers sitting on the couch one day, acutely aware of the strain on each of the muscles she was using in her neck and back to stay upright. "Just sitting was intensely exhausting," she says.
For five weeks in 2008, Domene endured a battery of scans, blood tests and a spinal tap, which finally confirmed a diagnosis of multiple sclerosis (MS), an autoimmune disease that develops when the body's own immune system begins to destroy the protective sheath that surrounds nerve cell fibers throughout the body and brain, like insulation around electrical wires.
As her nerves were being stripped, she was experiencing some of the broad range of MS symptoms that result from chaotic and interrupted nerve signaling in her body. Scans revealed six lesions in Domene's brain and two on her upper spine—a 1.5 centimeter lesion in her upper neck and a smaller one just beneath it. Given its presentation, her MS was classified as "aggressive."
Doctors in Albuquerque, New Mexico, offered Domene, a native of Brazil, a choice of injectable drugs called interferons. However, she was frightened by the long list of common side-effects of these drugs, including black tarry stools, fever, nausea and diarrhea, joint and muscle pain, headache, mouth and lip ulcers, fatigue, difficulty urinating, "unusual bleeding or bruising" and more.
Instead, Domene chose a common alternate drug, copaxone, because it had fewer side-effects—namely anxiety, chest pain and pounding heart, joint, neck and muscle pain and hives. Her neurologist told her that capoxone could prevent perhaps 30 percent of future relapses, and it may or may not slow down her disease progression. Not the best odds, she thought, but she agreed.
Domene also started looking into alternatives and found an MS support group that advised the "Best Bet Diet," which eliminates gluten, dairy, sugar, soy and a few other foods known to commonly trigger the immune system.
It also suggested taking supplements, including 5,000 IU of vitamin D daily—a dose way beyond the 600 to 800 IU recommended by most health agencies following the guidelines of the Institute of Medicine.1 She started doing both.
Link to autoimmune disease
Way back in 1960, Irish physician and epidemiologist Donald Acheson was the first to link the high prevalence of MS in northern countries compared to those in lower latitudes to their available hours of sunlight exposure. The idea was ridiculed at the time, but the last 50 years of research has confirmed his findings.
The incidence of MS in the sunnier southern US is about 57-78 cases per 100,000 people, for example, compared to 110-140 cases in the colder, darker northern states.2
Especially in the past decade, an explosion of vitamin D research has shown that many other diseases where the immune system has turned in attack on its own body, including autoimmune alopecia, inflammatory bowel disease, lupus, psoriasis, rheumatoid arthritis and diabetes, are also linked to low vitamin D levels. The lower the vitamin D, the worse the disease picture.
What's more, recent studies have suggested that vitamin D supplementation can bring about clinical improvements in people suffering from autoimmune Crohn's disease, rheumatoid arthritis, and type 2 diabetes. The vitamin is thought to help by controlling the production of key molecules that regulate the immune system, such as interleukin 17.3
Back in 2010, about a year after Domene began taking copaxone, University of Toronto researchers reported their study findings that patients who received an average of 14,000 IU/day of vitamin D3—to doses as high as 40,000 IU/day—had just a 16 percent incidence of MS relapse, compared with 38 percent of MS patients in the control group, who took an average of just 1,000 IU/day over the course of a year.4
Even before that study was published, Domene was seeing people claim on MS forums that they felt better taking doses of vitamin D as high as 10,000 IU/day—what top vitamin D researcher Michael Holick had described as a dose that all teens and adults could "easily tolerate ... without concern for toxicity." 5
Domene had been reading everything she could about vitamin D and MS, and she was considering upping her own vitamin D dose when a friend of hers from Brazil called her out of the blue to chat. Her friend said that Isabel, another mutual friend of theirs, had also been diagnosed with MS four years earlier but had started seeing a specialist in São Paulo who prescribed high-dose vitamins. Isabel was doing fantastic as a result.
No one knows she's got MS
As Domene eventually learned, after Isabel's MS diagnosis, she had started taking an interferon drug called avonex, which proved ineffective, when her pharmacist told her about Cicero Galli Coimbra, a neurologist and professor of neuroscience at the Federal University of São Paulo. He was prescribing massive doses of vitamin D to MS patients and seeing remarkable results.
Isabel booked an appointment and began to feel less fatigued almost immediately after starting vitamin D at 25,000 IU per day. After a few months on the protocol, her MRI scans showed no new disease activity or lesions, and she was feeling better than she had in years. Today Isabel is still completely free of MS relapses.
After hearing her friend's story, Domene started making plans to see Dr Coimbra herself.
'We decided to consider the interest of the patient'
As a postdoctoral student at the University of Lund in Sweden, Coimbra read about vitamin D's ability to stimulate nerve regeneration and its potential as a therapy for neurodegenerative conditions. A decade later, while practicing as a clinical neuroscientist in Brazil, he began treating his patients with Parkinson's disease with 10,000 IU of vitamin D per day—a safe dose that mimics 10 or 20 minutes of sunbathing in a healthy person.
One of these patients also suffered from vitiligo, an autoimmune condition that causes the skin to lose its pigmentation in sharply defined areas that look like white blotches on dark skin. When the patient returned for a check-up three months after starting vitamin D supplementation, Coimbra noticed that a large vitiligo patch on the man's face was no longer clearly visible.
This led Coimbra to dig deeper into the effects of vitamin D, and he discovered a large body of research describing its potent ability to regulate the immune system—and thus its potential to treat all sorts of autoimmune conditions.
As most of his patients with MS were vitamin D deficient, Coimbra started prescribing them 10,000 IU of vitamin D daily as well, and he began to see remarkable improvements.
Optimizing the protocol
Over the next decade, Coimbra continued testing his MS patients' vitamin D levels, monitoring them for potential side-effects from excessive vitamin D and gradually raising doses. He also tested for when higher or lower doses of vitamin D were needed.
For example, when parathyroid hormone (PTH, also called parathormone) is lowered, vitamin D is more active because PTH is a natural antagonist of vitamin D. The Coimbra protocol aims to get PTH levels down to the low end of the normal reference range, so that vitamin D activity is optimized.
Coimbra also began working with his colleagues, using his protocol on patients with other autoimmune diseases. He continued to see incredible results. In 2012, he and a team of researchers from the Federal University of São Paulo carried out a pilot study of 25 patients with vitiligo and psoriasis who were given daily doses of 35,000 IU vitamin D3.
All nine psoriasis patients in the trial experienced clinical improvements, and 14 of the 16 vitiligo patients had 25 to 75 percent repigmentation of affected skin.
Interestingly, the study did not include control patients because the researchers considered it unethical to withhold a treatment that would normalize recognized deficient serum levels of vitamin D.6
One photo in the study shows a man whose abdomen is almost covered with large, pink, flaky scales of psoriasis. A second photo, taken at the end of the six-month study, shows the same abdomen with virtually no trace of the disease.
Another before-and-after series shows a dark-skinned woman with about half her face covered by vitiligo patches of white skin, and almost no trace of the disease on her face six months later.
Despite mainstream medicine's fear of higher doses of vitamin D, real-world evidence of true vitamin D toxicity is rare. One study published in 2015, in which Mayo Clinic researchers tested vitamin D levels in 20,308 people over 10 years, found only four patients with hypercalcemia (abnormally high levels of calcium in the blood), one of which was severe enough to cause clinical symptoms, in a person whose vitamin D (25(OH)D) blood concentration was astronomically high, at 364 ng/mL (equivalent to 910 nmol/L).7
That fit with other findings, including those of a Canadian study which found that adults who ingested up to 20,000 IU of vitamin D3 per day had a significant increase of 25(OH)D concentrations, up to 60 ng/mL (150 nmol/L), with no evidence of toxicity.8
The sunshine vitamin
Vitamin D is not a vitamin at all—it was misnamed as such when it was discovered in the early 20th century, but it is actually a hormone made in the skin from sunlight. Its role in bone health has been known for decades—a deficiency can cause soft bones and rickets.
In recent years, however, vitamin D has been shown to play a role in thousands of vital processes in the body. It promotes gut health, protects the lining of the gut from becoming "leaky" or permeable, an underlying factor in many diseases, and alters the microbiome.
It is a powerful modulator of the immune system (tamping down and revving up activity as needed). It also influences the expression of hundreds of genes. Whether genes are turned 'on' or 'off' can influence the expression of disease, and so it is not surprising that vitamin D has been linked to more than 55 different conditions, including autoimmune disease, cancer and cardiovascular disease, depression, obesity and schizophrenia.1
Domene's neurologist in New Mexico was not opposed to her plan to take high-dose vitamin D - she just thought it was a waste of time and money. However, she was willing to order the tests Domene asked for. Her primary care physician also agreed to do the follow-up tests as needed.
Domene had already begun taking 15,000 IU of vitamin D daily on Coimbra's preliminary advice and feeling her fatigue improve, but when she saw him in person, he increased her dose to 25,000 IU, and she stepped out into the Brazilian sunshine full of optimism. Besides vitamin D, Domene continued on the elimination diet; though it had not helped her symptoms, she wanted to keep eating healthily. She was also taking the supplements that Dr Coimbra had recommended, which included:
• Two capsules (500 mg each) of DHA-rich omega 3 fish oil per day (though she started off taking six a day)
• 800-1,200 mg per day of magnesium glycinate or citrate
• 100 mcg of vitamin K2, which promotes calcium absorption into bones and teeth and prevents it from accumulating in soft tissues
• 200 mcg of selenium
• B vitamin complex including vitamin B2 (riboflavin), vitamin B6 (pyridoxine) and vitamin B12.
Domene says that her fatigue improved more quickly, but it took six or seven months before she noticed real changes. "My right arm was not as clumsy, and I was able to tie a shoelace and hold a glass of water without spilling it."
With her PTH reading still high, Dr Coimbra raised her vitamin D dosage to 50,000 IU daily, and she continued to improve. About 16 months after starting the protocol, she went for her first MRI since her diagnosis. Her tests showed no new disease activity, no new lesions, and the small lesion on her cervical spine had disappeared. "I was ecstatic," Domene says. "I hugged my doctor."
However, at a later appointment, her primary care doctor noticed her blood pressure was high, and Domene mentioned she had heart palpitations. He ordered an EKG, but it looked normal. A few weeks later, she felt anxious and had a tight feeling, like bands around her chest. Her palpitations were getting worse.
This time, her doctor realized that these symptoms were side-effects of the capoxone she had been taking since her diagnosis. Domene called her neurologist that day, who stopped the capoxone altogether. The anxiety and heart symptoms disappeared within a few weeks. "That's when I really felt the last of my fatigue go," Domene recalls.
What is a toxic dose?
Coimbra insists that correcting vitamin D deficiency is not as simple as gobbling huge amounts of the supplement. His patients taking high-dose vitamin D have their blood and urine monitored for excess calcium due to vitamin D.
Excess calcium—or hypercalcemia—is the primary toxicity of vitamin D that many doctors fear. Excess calcium can, paradoxically, weaken rather than strengthen bones and may also form into kidney stones.
High calcium levels can also interfere with heart and brain function, and symptoms include confusion, apathy, nausea, vomiting and abdominal pain.
In its latest report on dietary reference intake of vitamin D, the Institute of Medicine found no evidence of toxicity at vitamin D consumption levels up to 10,000 IU daily, but the agency still "cautiously" set the maximum safe level of consumption at just 4,000 IU per day and recommended intake of just 600 IU per day.1
It also stated that blood vitamin D levels of 20-30 ng/mL (50-75 nmol/L) were "sufficient" for 97.5 percent of the population.
These guidelines have been contested by numerous vitamin D experts.
Reinhold Veith, a vitamin D researcher at the University of Toronto aligned with the Endocrine Society, which recommends that, for adults, 1,500-2,000 IU/day is required for basic musculoskeletal health, noted that obese adults require two to three times more vitamin D to sustain a vitamin D blood level of at least 75 nmol/L, simply to prevent vitamin D deficiency-induced bone softening.2
Others, like osteopath and vitamin D champion Dr Joseph Mercola, have advised that 40 ng/mL (100 nmol/L) is the bottom cutoff for vitamin D serum levels that optimize health and disease prevention.
Ideally, according to Mercola, people should shoot for 60-80 ng/mL (150-200 nmol/L). Many adults have to consume more than 10,000 IU of vitamin D per day to achieve that.
For the next few years, Domene experimented with diets and eventually switched to the paleo diet. Dr Coimbra raised her vitamin D to 60,000 IU per day, and she continued to watch her dairy intake to keep her calcium in check. Then in 2011, she began experiencing reflux and had a constant bitter taste in her mouth.
Her doctor prescribed a proton pump inhibitor, omeprazole, to lower her stomach acid, but it made things worse. Her throat became inflamed. Now, she found herself unable to eat, and her symptoms were getting worse.
Domene saw two specialists and had a battery of tests and scans, but all her results were normal. She eventually booked an appointment with Samuel Walters, a functional physician in Scottsdale, Arizona who did a Heidelburg test for stomach acid, which confirmed that she was severely acid deficient. The drugs she had been taking were intensifying her problem.
Low stomach acid is a common problem that affects people as they age, and it is especially prevalent among people with autoimmune diseases like MS. It has been linked to a leaky gut, which has been identified as a major factor in the development of autoimmunity.
Domene began to take proteolytic enzymes with each meal and soon added in Betaine HCL. The lump in her throat, her bloating and the bitter taste in her mouth all disappeared, and since then she has been able to cut her dose of enzymes in half.
Back on her high vitamin D protocol, Domene went for her routine neurology scans and after nearly five years of unchanged MRIs, had a pleasant surprise—not only were there no new lesions, but her large lesion between C2 and C3 had shrunk from 1.6 cm to 1.4 cm.
Today Domene remains relapse-free. Her only symptom of MS is some tingling in her hands, which she believes is due to nerve damage from the early disease.
In 2016 she published a book, Multiple Sclerosis and (lots of) Vitamin D (Odyssey Books). It shares the stories of a dozen more patients of Dr Coimbra—mostly people who were diagnosed with MS, but it also includes the stories of a teacher with severe psoriasis, which disappeared, and a woman diagnosed with Crohn's disease and ankylosing spondylitis, who is now completely symptom-free.
On social media, the Coimbra Protocol North America Facebook page has more than 10,000 members and growing, and the numbers of doctors who are using the protocol is continually expanding. Coimbra is increasingly featured in the mainstream media in Brazil, where dozens of doctors use his protocol now. More than 55 physicians across Europe are cited on the protocol web page, including in Germany, Italy and Austria, and there is a growing number of practitioners across the globe.
For Domene, after 12 years without a relapse and many years of living symptom-free, the experience of battling MS is a fading memory. "I feel great," she says. "I just don't even think of MS anymore."
Coimbra says that people with autoimmune disease require abnormally high doses of vitamin D because they are "resistant" to the hormone. Nevertheless, he is cautious, and his protocol advises high dosing of vitamin D only under the supervision of a physician. There is no one-size-fits-all dose prescription in the protocol; every patient has to have a battery of tests to determine the appropriate amount of vitamin D and to rule out unsuitable candidates, such as those with high parathyroid hormone or those with sensitivity to vitamin D.
These tests include (but are not limited to):
• Vitamin B12
• Vitamin D (both 1,25(OH)2D3 [calcitriol] and 25(OH)D3)
• Parathyroid hormone (PTH)
• Blood urea nitrogen
• Total calcium and ionized calcium
• Total calcium in urine (24-hour volume)
• Serum phosphate
• DXA (bone density) scan
Patients on the protocol are also advised to follow a diet that restricts calcium. Dairy products are excluded, except those used in small quantities in recipes. So, milk and cheese are out, but mashed potatoes made with a bit of butter would be in. Patients are told to limit their consumption of nuts high in calcium and to only eat small quantities of high-calcium vegetables like spinach, so daily spinach smoothies are out, too.
Patients are additionally instructed to drink 2.5 liters of water each day to help flush the kidneys of calcium deposits and to engage in regular, bone-strengthening exercise.
The Coimbra Protocol: