Dr. Basen takes a look at recent studies focused on vitamin D and omega 3 There have been several trials that have looked at how to slow the progression of type 1 diabetes (T1D), including use of vitamins to prevent inflammation. A study was initiated in July 2018 looking at 56 patients with type 1 diabetes randomized to taking high dose vitamins or 25-OH vitamin D alone or in combination with ultra-refined omega 3 EPA/DHA derived from fish oil. Patients were stratified into patients who were diagnosed less than 6 months or greater than 6 months, but less than 10 years prior. Treatment duration is planned for 1 year with one year follow-up to obtain measures of long-term effect on blood sugar. Dosing will be adjusted based on higher levels of arachidonic acid to eicosapentaenoic acid (EPA). Elevated EPA is thought to aid in reduction of inflammation. A case of an 8-year-old with new onset type 1 diabetes at Miami Miller School of Medicine who was prescribed daily vitamin D supplementation with compelling results prompted the current study. At 5 months post-diagnosis, he was started on high-dose omega-3-fatty acids to decrease inflammation. Sixteen months post-diagnosis, the patient demonstrated improvement in blood sugars, reduced insulin requirements, and improvement in C-peptide levels. Another study in 2017 provided administration of 50,000 IU of vitamin D3 biweekly to 70 subjects with T1D. Of the 65 that completed the study, there were decreased fasting blood sugar and HbA1c levels. Importantly, calcium and alkaline phosphate levels remained stable. Dosing of vitamin D and whether effects are long-lasting are unclear. Other previous studies examined the potential role in vitamin D supplementation for those newly diagnosed with type 1 diabetes. There have also been several studies suggesting that those with longstanding T1D and demonstration of vitamin D deficiency be treated with supplementation. Full Critique Many trials have posed the question: "Is there a way to slow the progression of type 1 diabetes (T1D) or islet cell destruction?" Additionally, in individuals with more longstanding T1D: "Are there other dietary measures such as vitamin supplementation specifically aimed at reducing inflammation that can aid in blood glucose management?" In July 2018, a clinical trial was initiated by the Diabetes Research Institute (DRI) that aims to explore the effects of omega-3 fatty acids and vitamin D on the disease. More specifically, the trial will analyze potential effects on reducing inflammation, halting autoimmunity, and increasing insulin sensitivity and secretion in both an adult and pediatric population. The study recruited 56 adults and children with T1D into a two-arm, open-label study. They were then further stratified into individuals with T1D who were newly diagnosed in the past 6 months and those diagnosed greater than 6 months but less than 10 years prior. The participants of the study were then randomized to taking high dose vitamin D or 25-hydroxyvitamin D alone or in combination with ultra-refined omega 3 EPA/DHA derived from fish oil. The treatment duration will be one year along with a one-year follow-up period to obtain outcome measures of long-term effect on blood sugar control or increase in endogenous insulin production The dosing is based on factors such as age and body weight, however, it will be altered every four months according to monthly levels of the ratio of arachidonic acid to eicosapentaenoic acid (AA/EPA). It is known that higher levels of AA promotes an environment of elevated inflammation and dampens the effects of regulatory T-cells. On the other hand, elevated EPA is thought to be protective and aid in the reduction of inflammation. DRI initially was funded by the FDA because of promising results found in a case of an 8-year-old boy with new onset T1D at Miami Miller School of Medicine published in the European Review for Medical and Pharmacological Sciences. Initial lab studies, which confirmed the diagnosis of diabetes, also demonstrated low levels of vitamin D and he was thus prescribed daily vitamin D supplementation. Additionally, at five months post diagnosis, he was prescribed high-dose omega-3 fatty acids to potentially decrease ongoing inflammation and was continued on a gluten-free, high-fiber diet. Sixteen months post-diagnosis the patient demonstrated improved blood sugar management, reduced requirement of daily insulin, and increased levels of C-peptide, which is used as a biomarker for native pancreas function. More specifically, the patient now only required 0.05 units per kg per day, compared to 0.39 units per kg at diagnosis. Additionally, C-peptide levels increased from 0.5mg/ml at diagnosis to 0.6 mg/ml (fasting) and 1.6 mg/ml (post-meal). Other previous studies examined the potential role in vitamin D supplementation for those newly diagnosed with type 1 diabetes. There have also been several studies suggesting that those with longstanding T1D and demonstration of vitamin D deficiency be treated with supplementation. For example, another study in 2017 provided administration of 50, 000 IU of vitamin D3 biweekly to 70 subjects with T1D. Of the 65 that completed the study there was demonstration of decreased fasting blood sugar and HbA1c levels. Importantly, calcium and alkaline phosphate levels remained stable. Many of these studies demonstrate promising results albeit are preliminary. It is still unclear as to what would be a safe and appropriate dosing of vitamin D and whether the effects remain after cessation of supplementation. Nonetheless, it is important for healthcare professionals to be cognizant of ongoing and promising research on type 1 diabetes. Source
