Adult and pediatric Type 1 diabetes patients are being sought for a clinical trial to test if high doses of omega-3 and vitamin D can halt the progression of the disease.
The Diabetes Research Institute at the University of Miami Miller School of Medicine is conducting the trial.
The Poseidon Trial will study the safety and effectiveness of the two oral medications, with the hope that it may slow or stop the progression of the autoimmune process and preserve insulin-producing cells, essentially halting Type 1 diabetes from developing further.
In type 1 diabetes, the body does not produce insulin, which the body needs to get glucose from the bloodstream into the cells.
Scientific reports have suggested that high-dose omega-3 and vitamin D supplementation may improve autoimmune conditions like Type 1 diabetes.
“What has been found is that omega-3 and vitamin D, above a certain dose, become both anti-inflammatory and immunomodulatory,” meaning that they can change and regulate the body’s immune system, said Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami.
Inflammation may be one of the triggers for autoimmunity that leads to the onset of the disease. It also may also affect insulin resistance, Ricordi said in a statement announcing the trial.
Results from a recent case study examining the role of omega-3 and vitamin D in preserving beta cell function (to store and release insulin) in three pediatric patients with Type 1 diabetes warranted further investigation of the therapeutic strategy, he said.
“The combination of the two are safe and very inexpensive compared to other expensive biologic drugs that are being tested, so I think it is a safe, affordable alternative that can have a profound impact on not just Type 1 diabetes, but autoimmune conditions in general,” Ricordi said.
The Diabetes Research Institute is enrolling 56 adults and children ages 6 to 65 with Type 1 diabetes, both newly diagnosed and those who were diagnosed more than six months ago. Study participants will take either vitamin D alone or in combination with omega-3 for one year, followed by a one-year observation period.
“We are at the very beginning…and I am very excited to able to test this hypothesis,” Ricordi said.
But he is cautious about creating hype about the therapy before it is tested.
“One of our problems is once you explain the trial, it’s so simple people are trying it on their own,” he said. In fact, there are tests that can be secured online to monitor omega-3 and vitamin D levels by doing a simple finger stick and mailing off a blood sample.
“But it should be done under medical supervision. I cannot recommend that anyone do a trial that is not proven yet,” Ricordi said. “I recommend enroll in the trial and get validation of the hypothesis or discuss this with your physician.”
It is also important to use a highly purified form of omega-3.
“You don’t want to get a cheap product that may have contaminants like mercury, especially if you are taking them at a higher dose,” he said.
Studying the effects of omega-3 and vitamin D could change health care as we know it, Ricordi said.
“There are trials studying the effects of the combination of omega-3 and vitamin D to prevent cardiovascular disease, stroke and cancer,” he said. “You’ll see many more trials coming up on this topic.”