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

NCT03406897 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20180173
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Diabetes Mellitus; Diabetes, Autoimmune

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Hemoglobin A1c Level

  Baseline and 1-Year Visit

• Change in Insulin Requirements

  Baseline and 1-Year Visit

• Number of Adverse Events (AE)

  Through study completion, and average of one year

Study Arms (2)

Omega-3 and Vitamin D Combination

ACTIVE COMPARATOR

The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.

Drug: Cholecalciferol; Drug: Omega 3 fatty acid

Vitamin D Only

ACTIVE COMPARATOR

The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

Oral Administration

Also known as: Vitamin D

Omega-3 and Vitamin D Combination; Vitamin D Only

Omega 3 fatty acid DRUG

Oral Administration

Also known as: Omega 3

Omega-3 and Vitamin D Combination

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Rodolfo Alejandro: lead
• Diabetes Research Institute Foundation: collaborator

Study Sites (1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 27467009 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Diabetes Mellitus

Interventions

Cholecalciferol; Vitamin D; Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. David Baidal
• Organization: University of Miami, Diabetes Research Institute

dbaidal@med.miami.edu

305-243-7740

Study Officials

• Camillo Ricordi, M.D.

  Professor and Center Director of Diabetes Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: The study is a two-arm, open label, randomized trial. All four groups will receive standard intensive diabetes treatment with insulin and dietary management. Group I: Fourteen (14) adults (18-65 years) of established T1D \> 6 months (\>180 days) and up to 10 years of T1D duration Group II: Fourteen (14) adults (18-65 years) of new-onset T1D diagnosed within last 6 months (≤ 180 days) Group III: Fourteen (14) children (6-17 years) of established T1D \> 6 months (\>180 days) and up to 10 years of T1D duration Group IV: Fourteen (14) children (6-17 years) of new-onset T1D diagnosed within last 6 months (≤ 180 days) Participants in each group will be randomly assigned in a 1:1 ratio to receive either one year of high dose Omega-3 fatty acids and Vitamin D combination (Arm A) or Vitamin D alone (Arm B). Both arms will receive Vitamin D supplementation.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 23, 2018
• Study Start: July 23, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)