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: Completed
• 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 (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Diabetes Research Institute, University of Miami Miller School of Medicine

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:

• Subject must be able to understand and provide informed consent.
• Males and females, 6-17 years for children and 18-65 years of age for adult group.
• For new onset T1D - from onset to 6 months (180 days) post-diagnosis at the time of randomization.
• For established T1D - At least 6 months and up to 10 years from the diagnosis at the time of randomization.
• 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 autoantibody (if patient has been treated with insulin for less than 2 weeks).
• T1D must be treated with insulin (except if participant is in Honeymoon period/phase).
• Stimulated C-peptide peak level, at the baseline 1 visit MMTT, ≥ 0.2 ng/ml.
• Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
• Adequate venous access to support study required blood draws.

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.

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
Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide	Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit	Baseline and 1-Year Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c Level	Change in HbA1c between baseline and 1-year	Baseline and 1-Year Visit
Change in Insulin Requirements	Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day	Baseline and 1-Year Visit
Number of Adverse Events (AE)	Number 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 (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

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): September 17, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 1; Fatty Acids; Lipids; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Eicosanoids; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fish Oils; Cholestenes; Cholestanes; Sterols; Secosteroids; Membrane Lipids; Vitamin D; Cholecalciferol; Eicosapentaenoic Acid; Fatty Acids, Omega-3
• Other Study ID Numbers: 20180173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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