Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (NCT03406897) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients
United States27 participantsStarted 2018-07-23
Plain-language 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.
Who can participate
Age range6 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide