Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients

Exclusion Criteria

• •Patients must not meet any of the following criteria to be eligible to participate:
• •Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• •BMI\>30 kg/m2.
• •Contra-indications to any of the drugs used in the trial (as per package insert, e.g., knowledge of hypersensitivity to drugs or its excipients).
• •Uncompensated heart failure, fluid overload, myocardial infarction or liver disease or severe impairment of a vital organ within the last 6 weeks before enrollment.
• •Any of the following laboratory findings indicating hemoglobin \<10.0 g/dL; leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL.
• •Any sign or diagnosis of significant chronic active infection (e.g., hepatitis, tuberculosis, EBV, or CMV), or screening laboratory evidence consistent with a significant chronic active infection (such as positive for HIV, IGRA test for TB, or hepatitis B-C).
• •Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.
• •Ongoing or anticipated use of diabetes medications other than insulin.
• •Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening.
• •Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
• •Use of investigational drugs within 3 months of participation.
• •Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
• •History or diagnosis of malignancy, with the exception of a history of localized basal or squamous cell carcinoma.
• •History of gastroparesis or other severe gastrointestinal disease..
• •Presence of an allograft.
• •AST, ALT or Alkaline Phosphatase \>2 times upper limit of normal or total bilirubin \>1.5 times upper limit of normal.
• •History of mental illness deemed to be clinically unstable or any situation that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
• •History of illicit drug or alcohol abuse.
• •Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire duration of the study.
• •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.