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

NCT03406897 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-09-17

Study results available
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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

Interventions

DRUG

Cholecalciferol

Oral Administration

DRUG

Omega 3 fatty acid

Oral Administration

Sponsors & Collaborators

  • Diabetes Research Institute Foundation

    collaborator OTHER

  • Rodolfo Alejandro

    lead OTHER

Principal Investigators

  • Camillo Ricordi, M.D. · Professor and Center Director of Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406897 on ClinicalTrials.gov