Omega-3 and Vitamin D Combination for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 1 Diabetes+3 MoreCholecalciferol - Drug
Eligibility
6 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a combination of Omega-3 Fatty Acids and Vitamin D are safe and effective, considering when and how long they are taken.

Eligible Conditions
  • Type 1 Diabetes
  • Low Blood Sugar
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Through study completion, and average of one year

Through study completion, and average of one year
Hemoglobin A1c Level Reduction
Incidence of Adverse Events (AE)
MMTT (Mixed Meal Tolerance Test)
Reduction in Insulin Requirements

Trial Safety

Trial Design

2 Treatment Groups

Omega-3 and Vitamin D Combination
1 of 2
Vitamin D Only
1 of 2

Active Control

56 Total Participants · 2 Treatment Groups

Primary Treatment: Omega-3 and Vitamin D Combination · No Placebo Group · Phase 1 & 2

Omega-3 and Vitamin D CombinationActiveComparator Group · 2 Interventions: Cholecalciferol, Omega 3 fatty acid · Intervention Types: Drug, Drug
Vitamin D Only
Drug
ActiveComparator Group · 1 Intervention: Cholecalciferol · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, and average of one year

Who is running the clinical trial?

Rodolfo AlejandroLead Sponsor
9 Previous Clinical Trials
206 Total Patients Enrolled
Diabetes Research Institute FoundationOTHER
9 Previous Clinical Trials
131 Total Patients Enrolled
Camillo Ricordi, M.D.Study DirectorProfessor and Center Director of Diabetes Research Institute
2 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 6 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum age of 6 years and a minimum age of 65 years.
You are female and you are of childbearing potential.
You must have adequate venous access to support the study.