NCT03406897

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

A Pilot, Safety and Feasibility Trial of High-Dose Omega-3 Fatty Acids and High-Dose Cholecalciferol (Vitamin D) Supplementation in Type 1 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Rodolfo Alejandro · Academic / Other
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Diabetes Mellitus
• Diabetes, Autoimmune

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Oral Administration
DRUG	Omega 3 fatty acid	Oral Administration

Timeline

• Start date: 2018-07-23
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2018-01-23
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study