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Can fish oil and vitamin d help preserve insulin in type 1 diabetes?

NCT ID NCT03406897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested whether high doses of omega-3 fatty acids (fish oil) and vitamin D are safe and can help preserve insulin production in people with type 1 diabetes. The trial included 27 participants, both children and adults, who had diabetes for up to 10 years. Researchers measured changes in C-peptide (a marker of insulin production) and blood sugar control over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omega-3 fatty acids and vitamin D (cholecalciferol)
What this could lead to
If it works, this could point toward a simple supplement approach to help preserve insulin production in people with type 1 diabetes.
What could go wrong
This is a small, early-phase pilot trial with only 27 participants, so results may not apply widely. High doses of supplements can also have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

27 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Miami, Florida, 33136, United States

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