Coimbra Protokoll Projects
Observational study on the Coimbra Protocol in MS
Additional study on Gene Expression Under High-Dose Vitamin D Therapy: The Coimbra Protocol
Observational study on the Coimbra Protocol in MS
After three years of planning, fundraising and delays caused by the pandemic, the observational study on the Coimbra Protocol in MS has finally begun at the Charité university hospital in Berlin.
What is the Coimbra Protocol in MS study?
Over three years, the study will observe 100 patients with relapsing-remitting multiple sclerosis who are just at the start of their treatment with a certified protocol doctor.
The aim of the observational study is, first of all, to prove that there is no risk of harm from the Coimbra Protocol if it is followed correctly. At the end of the observation period, the data from the study participants will be compared with similar cases from the Charité’s ongoing trials register to document the effectiveness compared with the pharmacological core treatments and/or treatment-naive individuals.
What makes this study so important?
In social networks there are many positive testimonials, especially with relapsing-remitting MS. There are more than 140 protocol doctors worldwide, who have so far treated around 30,000 patients with autoimmune diseases. Nevertheless, so far there have not been any studies on its long-term safety or on Dr Coimbra’s theory of a genetic vitamin D resistance. We at the non-profit Coimbraprotokoll gUGmbH want to change this by organising more research over the longer term and producing scientific documentation with reliable figures.
The three-year observational study on the Coimbra Protocol in MS, led by Prof. Friedemann Paul at the NeuroCure Research Center of the Charité university hospital in Berlin, marks the start of this strategy.
We are very grateful to the Falk-Stiftung für Gesundheit und Bildung in Nuremberg – a very generous, competent partner who is financing the entire study, including its preparation, for a period of four years.
The study is an important step towards convincing a wider public of the Coimbra Protocol, its safety and effectiveness.
Who can take part?
The study is open to patients with relapsing-remitting multiple sclerosis who have just started Coimbra Protocol treatment under the supervision of a certified protocol doctor, or have decided to do so and will start treatment soon. Your protocol doctor will have information leaflets about the study on display or will be able to provide them on request, if you or a patient you know with relapsing-remitting MS is interested.
The final selection of study participants will be made by the Charité team using criteria that have been defined in advance in consultation with the German Ethics Council to ensure that the observed group has a good mix of individuals. This will also ensure that the study is comparable with other MS studies.
Charité is running a purely observational study that will not influence patients’ medication-based treatment or other therapy. However, comprehensive examinations will take place, which may also provide additional information for the study participants.
It is possible to travel to Berlin and stay in a hotel for the purposes of a medical examination at any time.
There are still spaces available on the study!
What are the benefits?
Since the study is being financed through charitable donations, there is no payment for taking part. However, travel costs of up to €200 per visit to Charité will be reimbursed.
In addition, we have managed to secure D-Light-Full as a sponsor. Every study participant will receive a €200 voucher to spend on supplements in the online shop at www.d-light-full.de !
You will receive the voucher once you send us proof of your participation in the study by email: email@example.com
More details on the study design and on how patients can take
part can be found in the flyer and in the FAQs.
Please address queries directly to
Charité Berlin research clinic:
Study coordinator Jana Bigall
Telephone: +49 (0)30-450539040
Gene Expression Under High-Dose Vitamin D Therapy:
The Coimbra Protocol
An additional study associated with the observational study on the Coimbra Protocol in MS, led by Prof. Friedemann Paul at the NeuroCure Research Center of the Charité university hospital in Berlin.
This study hinges on us receiving enough donations to finance it. Make a donation to help us start the study this year!
In collaboration with Charité in Berlin and the University of Eastern Finland in Kuopio, under the leadership of Prof. Carsten Carlberg, we are currently planning an additional study on Gene Expression Under High-Dose Vitamin D Therapy: The Coimbra Protocol. As well as studying the clinical course of the disease and collecting data on safety, we want to investigate the impact of high-dose vitamin D therapy at the genetic level. What links can be observed between the administration of high doses of vitamin D, gene expression, the immune system and patient health?
- Do MS patients have vitamin D resistance and consequently a disorder affecting regulation of the endocrine system and immune function?
- Does this problem have a genetic cause?
- But, above all: Can high-dose vitamin D therapy remedy this and have a positive impact on the course of the disease, and maybe even relieve symptoms and enable patients to live a normal life?
Vitamin D3 plays a key role in immune system function, since it regulates hundreds of genes, including, significantly, immune cell genes. It determines how these genes are expressed – for instance when differentiating between foreign cells and the body’s own cells.
It is this key that the Coimbra Protocol uses to help patients with autoimmune diseases. But how exactly does it work?
We are expecting to discover why and how the therapy works. Ultimately, our aim is to produce scientific evidence of the mode of action of the Coimbra Protocol.
In the longer term, this will also lay the foundations for publicising the Coimbra Protocol as an option for all patients with autoimmune diseases.
The four-year study on “Gene Expression Under High-Dose Vitamin D Therapy: The Coimbra Protocol” needs financing of €950,000. An ambitious project! But we want to make use of this opportunity and are relying on the generosity of our donors.