Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (POSEIDON)
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|ClinicalTrials.gov Identifier: NCT03406897|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Hypoglycemia Diabetes Mellitus Diabetes, Autoimmune||Drug: Cholecalciferol Drug: Omega 3 fatty acid||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study is a two-arm, open label, randomized trial. All four groups will receive standard intensive diabetes treatment with insulin and dietary management.
Group I: Fourteen (14) adults (18-65 years) of established T1D > 6 months (>180 days) and up to 10 years of T1D duration Group II: Fourteen (14) adults (18-65 years) of new-onset T1D diagnosed within last 6 months (≤ 180 days) Group III: Fourteen (14) children (6-17 years) of established T1D > 6 months (>180 days) and up to 10 years of T1D duration Group IV: Fourteen (14) children (6-17 years) of new-onset T1D diagnosed within last 6 months (≤ 180 days)
Participants in each group will be randomly assigned in a 1:1 ratio to receive either one year of high dose Omega-3 fatty acids and Vitamin D combination (Arm A) or Vitamin D alone (Arm B). Both arms will receive Vitamin D supplementation.
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Safety and Feasibility Trial of High-Dose Omega-3 Fatty Acids and High-Dose Cholecalciferol (Vitamin D) Supplementation in Type 1 Diabetes|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Omega-3 and Vitamin D Combination
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Other Name: Vitamin D
Drug: Omega 3 fatty acid
Other Name: Omega 3
Active Comparator: Vitamin D Only
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Other Name: Vitamin D
- MMTT (Mixed Meal Tolerance Test) [ Time Frame: Through study completion, and average of one year ]Stimulated (90 minute sample of a MMTT) C-peptide greater or equal to baseline level.
- Hemoglobin A1c Level Reduction [ Time Frame: Through study completion, and average of one year ]Reduction in HbA1c at the one year visit compared to baseline
- Reduction in Insulin Requirements [ Time Frame: Through study completion, and average of one year ]Reduction in insulin requirement at the 1 year visit compared to baseline
- Incidence of Adverse Events (AE) [ Time Frame: Through study completion, and average of one year ]Incidence of adverse events (AE) comparable to general diabetes population
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406897
|Contact: David A Baidal, M.D.||(305) 243-7740 ext firstname.lastname@example.org|
|Contact: Rodolfo Alejandro, M.D.||(305) 243-5324||RAlejand@med.miami.edu|
|United States, Florida|
|Diabetes Research Institute, University of Miami Miller School of Medicine||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Rodolfo Alejandro, M.D. 305-243-5324 email@example.com|
|Contact: David A Baidal, M.D. (305) 243-7740 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Alejandro, M.D.|
|Principal Investigator: David A Baidal, M.D.|
|Study Director:||Camillo Ricordi, M.D.||Professor and Center Director of Diabetes Research Institute|