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

A Pilot, Safety and Feasibility Trial of High-Dose Omega-3 Fatty Acids and High-Dose Cholecalciferol (Vitamin D) Supplementation in Type 1 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1; Diabetes, Autoimmune
• Intervention / Treatment: Drug: Cholecalciferol; Drug: Omega 3 fatty acid

Detailed Description

These agents may afford promote sustained immune regulation, reduce inflammation, and provide support for the residual beta cell mass. This integrated therapeutic regimen addresses major pathogenic mechanisms in T1D (Type 1 Diabetes) and thus represents a rational and well supported approach to preserve insulin secretion in T1D (Type 1 Diabetes). This approach could halt the disease progress, preserve β-cell function and hopefully reduce dose of insulin required to manage T1D (Type 1 Diabetes). The investigator hypothesizes that Omega-3 Fatty Acids and Vitamin D, administered to patients with newly or established T1D (Type 1 Diabetes) and residual stimulated C-peptide secretion will be safe and may preserve insulin secretion.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: David A Baidal, M.D.; Phone Number: 6-7740 (305) 243-7740; Email: dbaidal@med.miami.edu
• Study Contact Backup: Name: Rodolfo Alejandro, M.D.; Phone Number: (305) 243-5324; Email: RAlejand@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Diabetes Research Institute, University of Miami Miller School of Medicine
      • Contact: Rodolfo Alejandro, M.D.; Phone Number: 305-243-5324; Email: ralejand@med.miami.edu
      • Contact: David A Baidal, M.D.; Phone Number: (305) 243-7740; Email: dbaidal@med.miami.edu
      • Principal Investigator: Rodolfo Alejandro, M.D.
      • Principal Investigator: David A Baidal, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omega-3 and Vitamin D Combination; The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.	Drug: Cholecalciferol; Oral Administration; Other Names: Vitamin D; Drug: Omega 3 fatty acid; Oral Administration; Other Names: Omega 3
Active Comparator: Vitamin D Only; The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.	Drug: Cholecalciferol; Oral Administration; Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMTT (Mixed Meal Tolerance Test)	Stimulated (90 minute sample of a MMTT) C-peptide greater or equal to baseline level.	Through study completion, and average of one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c Level Reduction	Reduction in HbA1c at the one year visit compared to baseline	Through study completion, and average of one year
Reduction in Insulin Requirements	Reduction in insulin requirement at the 1 year visit compared to baseline	Through study completion, and average of one year
Incidence of Adverse Events (AE)	Incidence of adverse events (AE) comparable to general diabetes population	Through study completion, and average of one year

Collaborators and Investigators

• Sponsor: Rodolfo Alejandro
• Collaborators: Diabetes Research Institute Foundation
• Investigators: Study Director: Camillo Ricordi, M.D., Professor and Center Director of Diabetes Research Institute

Publications and helpful links

General Publications

• Baidal DA, Ricordi C, Garcia-Contreras M, Sonnino A, Fabbri A. Combination high-dose omega-3 fatty acids and high-dose cholecalciferol in new onset type 1 diabetes: a potential role in preservation of beta-cell mass. Eur Rev Med Pharmacol Sci. 2016 Jul;20(15):3313-8.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 20180173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No