Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The investigator propose to test the safety and efficacy of a regimen that combines Omega-3
Fatty Acids and Vitamin D in a design that considers timing and duration of administration in
relation to their effects and predicted synergies.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Other
Disease
Diabetes (Type I)
Enrollment Eligibility
Inclusion Criteria
Patients must meet all of the following criteria to be eligible to participate in this
study:
1. Subjects or their parents if under 18 years old must be able to understand and provide
informed consent.
2. Males and females, 6-65 years of age.
3. For new onset T1D subjects, ≤180 days from T1D diagnosis at the time of randomization
with a MMTT stimulated C-peptide peak level ≥0.2 ng/ml prior to randomization.
4. For established T1D subjects, >180 days and ≤10 years of T1D duration at the time of
randomization and MMTT stimulated C-peptide peak level ≥0.2 ng/ml prior to
randomization.
5. Affected by T1D, according to ADA standard criteria, and confirmed by positivity of at
least one T1D-associated autoantibody, to GAD65, IA-2, ZnT8, or insulin autoantibodies
(if patient has been treated with insulin for less than 2 weeks).
6. Female subjects of childbearing potential must have a negative pregnancy test upon
study entry.
7. Adequate venous access to support study required blood draws.
Exclusion Criteria
Potential participants must not meet any of the following exclusion criteria:
1. Inability or unwillingness of a participant or their parents to give written informed
consent or comply with study protocol.
2. BMI>30 Kg/m2.
3. Contra-indications to Omega-3 Fatty Acids and/or Vitamin-D (e.g., knowledge of
hypersensitivity to drugs or its excipients, allergies with fish or shellfish etc.).
4. Uncompensated heart failure, fluid overload, myocardial infarction or liver disease or
severe impairment of a vital organ within the last 6 weeks before enrollment.
5. 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).
6. Ongoing acute infections, e.g., acute respiratory tract urinary tract, or
gastrointestinal tract infections.
7. Subjects on weight altering medications, such as Orlistat.
8. Subjects with eating disorders
9. Ongoing or anticipated use of diabetes medications other than insulin.
10. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control
within prior 7 days of screening.
11. People who chronically take drugs that affect bleeding time, such as anticoagulants
("blood thinners") or nonsteroidal anti-inflammatory drugs (NSAIDs), will not qualify
to enroll in the study.
12. Recent recipient of any licensed or investigational live attenuated vaccine(s) within
6 weeks of randomization.
13. Use of investigational drugs within 4 months of participation.
14. Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic
agents, or previous therapy less than 3 months from randomization.
15. History or diagnosis of malignancy.
16. History of gastroparesis or other severe gastrointestinal disease.
17. History or diagnosis of malignancy with the exception of a history of localized basal
or squamous cell carcinoma. There is conflicting evidence about whether omega-3 fatty
acids found in seafood and fish oil might increase the risk of prostate cancer. Until
additional research on the association of omega-3 consumption and prostate cancer risk
is conducted, subjects with family history of prostate cancer in a first-degree
relative will be excluded from the study.
18. Presence of an allograft.
19. AST, ALT or Alkaline Phosphatase >2 times upper limit of normal or total bilirubin
>1.5 times upper limit of normal.
20. History of a 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.
21. History of illicit drug or alcohol abuse.
22. 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.
23. 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.
24. All patients who have coagulation, bleeding, or blood disorders will be excluded due
to the effect of high dose of Omega 3 Fatty Acids on coagulation and bleeding process.