Trial Outcomes & Findings for Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (NCT NCT03406897)
NCT ID: NCT03406897
Last Updated: 2025-09-17
Results Overview
Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline and 1-Year Visit
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
Omega-3 and Vitamin D Combination
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Omega-3 and Vitamin D Combination
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients
Baseline characteristics by cohort
| Measure |
Omega-3 and Vitamin D Combination
n=12 Participants
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=15 Participants
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
15 participants
n=4 Participants
|
27 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1-Year VisitPopulation: Group A: 7/12 subjects completed 1year follow-up. Group B: 8/15 subjects completed 1year follow up.
Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit
Outcome measures
| Measure |
Omega-3 and Vitamin D Combination
n=7 Participants
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=8 Participants
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide
|
-1.23 ng/mL
Interval -1.6 to -0.17
|
-0.62 ng/mL
Interval -1.44 to -0.15
|
SECONDARY outcome
Timeframe: Baseline and 1-Year VisitPopulation: Group A: 7/12 subjects completed 1year follow-up. Group B: 8/15 subjects completed 1year follow up.
Change in HbA1c between baseline and 1-year
Outcome measures
| Measure |
Omega-3 and Vitamin D Combination
n=7 Participants
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=8 Participants
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Change in Hemoglobin A1c Level
|
0.00 percentage of HbA1c
Interval -0.3 to 2.5
|
-0.55 percentage of HbA1c
Interval -3.1 to 0.3
|
SECONDARY outcome
Timeframe: Baseline and 1-Year VisitPopulation: Group A: 7/12 subjects completed 1year follow-up. Group B: 8/15 subjects completed 1year follow up.
Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day
Outcome measures
| Measure |
Omega-3 and Vitamin D Combination
n=7 Participants
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=8 Participants
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Change in Insulin Requirements
|
0.16 units/kg/day
Interval 0.02 to 0.52
|
0.15 units/kg/day
Interval -0.2 to 0.87
|
SECONDARY outcome
Timeframe: Through study completion, and average of one yearNumber of adverse events (AE) comparable to general diabetes population
Outcome measures
| Measure |
Omega-3 and Vitamin D Combination
n=12 Participants
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=15 Participants
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Number of Adverse Events (AE)
|
31 number of adverse events
|
28 number of adverse events
|
Adverse Events
Omega-3 and Vitamin D Combination
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vitamin D Only
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omega-3 and Vitamin D Combination
n=12 participants at risk
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=15 participants at risk
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Gastrointestinal disorders
Acute perforated apendicitis
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Endocrine disorders
Diabetes Ketoacidosis
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Omega-3 and Vitamin D Combination
n=12 participants at risk
The treatment arm A includes Omega-3 Fatty Acids and Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
Omega 3 fatty acid: Oral Administration
|
Vitamin D Only
n=15 participants at risk
The treatment arm B (control group) will receive only Cholecalciferol (Vitamin D) supplement.
Cholecalciferol: Oral Administration
|
|---|---|---|
|
Gastrointestinal disorders
Acute appendicitis
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Right upper thigh abscess
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Streptococcal pharyngitis
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Infections and infestations
COVID-19 Infection
|
0.00%
0/12 • 1 year
|
20.0%
3/15 • Number of events 3 • 1 year
|
|
Endocrine disorders
Dyslipidemia
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hypoglycemia
|
25.0%
3/12 • Number of events 19 • 1 year
|
20.0%
3/15 • Number of events 16 • 1 year
|
|
General disorders
High Vitamin D levels
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/12 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
|
General disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
General disorders
Hyperphosphatemia
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Fecal incontinence
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Oily rectal discharge
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Influenza A
|
16.7%
2/12 • Number of events 2 • 1 year
|
0.00%
0/15 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Celiac Disease
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Blood and lymphatic system disorders
Elevated PT/INR
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Surgical and medical procedures
Wisdom Teeth Extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
Additional Information
Dr. David Baidal
University of Miami, Diabetes Research Institute
Phone: 305-243-7740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place