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Diabetes Mellitus, Type 1Phase 1/2POSEIDONNCT03406897

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

A Phase 1/2 study testing Cholecalciferol and Omega 3 fatty acid in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Rodolfo Alejandro at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 65 years
What is being tested?
Cholecalciferol and Omega 3 fatty acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
23 Jul 2018to 31 Jul 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes Research Institute, University of Miami Miller School of Medicine

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Cholecalciferol, Omega 3 fatty acid
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDrug

    Also called Vitamin D

    Oral Administration

  • Omega 3 fatty acidDrug

    Also called Omega 3

    Oral Administration

Study groups in NCT03406897
Study groupRoleWhat they receive
Omega-3 and Vitamin D CombinationActive comparatorThe treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Receives: Drug: Cholecalciferol; Drug: Omega 3 fatty acid
Vitamin D OnlyActive comparatorThe treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Receives: Drug: Cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 1-Year Visit

Secondary outcomes (3)

  1. Change in Hemoglobin A1c Level

    Change in HbA1c between baseline and 1-year

    Measured: Baseline and 1-Year Visit

  2. Change in Insulin Requirements

    Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day

    Measured: Baseline and 1-Year Visit

  3. Number of Adverse Events (AE)

    Number of adverse events (AE) comparable to general diabetes population

    Measured: Through study completion, and average of one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start23 Jul 2018
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406897
Sponsor's protocol ID
20180173
Acronym
POSEIDON
Status last verified
Aug 2025
First submitted
10 Jan 2018
Last updated
17 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27467009

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cholecalciferol and Omega 3 fatty acid in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Rodolfo Alejandro at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide (time frame: Baseline and 1-Year Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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