Trial Testing Vitamin D, Fatty Acids for Type 1 Diabetes

(905513, Pixabay)

12 July 2018. A clinical trial is underway testing vitamin D and omega-3 fatty acids in children and adults as a treatment for type 1 diabetes, the form of diabetes where the body does not produce insulin. The trial is led by and conducted at the Diabetes Research Institute at University of Miami in Florida.

Type 1 diabetes is an inherited autoimmune disorder where the beta cells in the pancreas do not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells. From 5 to 10 percent of people diabetes have the type 1 form, estimated at 1.25 million people in the U.S.

Miami’s Diabetes Research Institute is exploring the benefits of vitamin D and omega-3 fatty acids, found in fish and some oilseed plants like flax for people with type 1 diabetes. Among other benefits, omega-3 fatty acids have anti-inflammatory properties and are believed to improve immune system functioning. The institute team believes these properties can be translated into help for people with type 1 diabetes, to slow the progression or even stop the disease entirely.

Camillo Ricordi, director of the institute, says in an institute statement, “Results from our recent case studies examining the role of omega-3 and vitamin D in preserving beta cell function in three pediatric subjects with type 1 diabetes warrant further investigation of this potential therapeutic strategy.” Results of these cases were published in July 2016.

The early- and intermediate-stage clinical trial is recruiting 56 individuals with type 1 diabetes in a pilot test of these treatments. Participants range in age from 6 to 65, but must be diagnosed with the condition within the past 10 years. The group is randomly assigned into 4 sections, each with 14 participants, and 2 groups each of children and adults, divided further into those with type 1 diabetes that began within the previous 6 months, and those with the disorder for more than 6 months. The trial is testing high doses of cholecalciferol, a vitamin D dietary supplement only, compared to cholecalciferol plus highly refined omega-3 fatty acids derived from fish oil, over 1 year.

Individuals in the trial will be evaluated primarily for the ability of their bodies to produce insulin. Participants will be given a Mixed Meal Tolerance Test, usually a standard dietary mixed meal, such as the commercial supplements Boost or Ensure. Blood tests then measure blood glucose levels in response to the meal. These tests will be given over the 1 year period, as well as measures of insulin requirements and signs of adverse effects over the period.

“If combination omega-3 and vitamin D therapy is able to delay progression or halt autoimmunity in type 1 diabetes,” notes Ricordi, “this is expected to result in retention of insulin secretion, minimal use of exogenous insulin, and improved metabolic control thus minimizing the risks associated with unstable blood glucose levels.” The researchers believe if the trial is successful, the strategy may also benefit patients with other autoimmune disorders, such as Crohn’s, rheumatoid arthritis, and lupus.

Ricordi tells more about the trial in the following video.

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