Trial Outcomes & Findings for Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes (NCT NCT03046927)
NCT ID: NCT03046927
Last Updated: 2024-07-10
Results Overview
Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Baseline to 12 months at 3 months interval
Results posted on
2024-07-10
Participant Flow
Out of 48 enrolled participants, 36 met the inclusion criteria and were randomized to the treatment.
Participant milestones
| Measure |
Ergocalciferol
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.25 years
STANDARD_DEVIATION 2.76 • n=5 Participants
|
14.28 years
STANDARD_DEVIATION 2.86 • n=7 Participants
|
13.77 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
HbA1C
|
7.62 Percentage of HbA1C
STANDARD_DEVIATION 1.35 • n=5 Participants
|
7.47 Percentage of HbA1C
STANDARD_DEVIATION 1.69 • n=7 Participants
|
7.54 Percentage of HbA1C
STANDARD_DEVIATION 1.52 • n=5 Participants
|
|
Body mass index
|
22.03 kg/m^2
STANDARD_DEVIATION 5.41 • n=5 Participants
|
22.01 kg/m^2
STANDARD_DEVIATION 4.15 • n=7 Participants
|
22.02 kg/m^2
STANDARD_DEVIATION 4.73 • n=5 Participants
|
|
Fasting plasma glucose
|
125.83 mg/dl
STANDARD_DEVIATION 25 • n=5 Participants
|
111.13 mg/dl
STANDARD_DEVIATION 35.78 • n=7 Participants
|
118.91 mg/dl
STANDARD_DEVIATION 30.97 • n=5 Participants
|
|
Waist Circumference
|
76.16 cm
STANDARD_DEVIATION 14.83 • n=5 Participants
|
76.22 cm
STANDARD_DEVIATION 11.56 • n=7 Participants
|
76.19 cm
STANDARD_DEVIATION 13.14 • n=5 Participants
|
|
Height
|
156.12 cm
STANDARD_DEVIATION 12.77 • n=5 Participants
|
158.65 cm
STANDARD_DEVIATION 11.30 • n=7 Participants
|
157.38 cm
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Height Z-score
|
0.50 Z-score
STANDARD_DEVIATION 0.73 • n=5 Participants
|
0.48 Z-score
STANDARD_DEVIATION 1.18 • n=7 Participants
|
0.49 Z-score
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
weight
|
53.33 kg
STANDARD_DEVIATION 15.19 • n=5 Participants
|
56.16 kg
STANDARD_DEVIATION 14.66 • n=7 Participants
|
54.78 kg
STANDARD_DEVIATION 14.77 • n=5 Participants
|
|
Weight z-score
|
0.86 Z-score
STANDARD_DEVIATION 0.81 • n=5 Participants
|
0.67 Z-score
STANDARD_DEVIATION 0.68 • n=7 Participants
|
0.76 Z-score
STANDARD_DEVIATION 0.74 • n=5 Participants
|
|
Body mass index z-score
|
0.89 Z-score
STANDARD_DEVIATION 0.94 • n=5 Participants
|
0.74 Z-score
STANDARD_DEVIATION 0.68 • n=7 Participants
|
0.82 Z-score
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
systolic blood pressure
|
104.94 mmHg
STANDARD_DEVIATION 9.06 • n=5 Participants
|
106.44 mmHg
STANDARD_DEVIATION 10.60 • n=7 Participants
|
105.69 mmHg
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
diastolic blood pressure
|
64.72 mmHg
STANDARD_DEVIATION 9.14 • n=5 Participants
|
64.67 mmHg
STANDARD_DEVIATION 6.80 • n=7 Participants
|
64.69 mmHg
STANDARD_DEVIATION 7.94 • n=5 Participants
|
|
Total Daily Dose (TDD) Insulin
|
37 units/d
STANDARD_DEVIATION 29.61 • n=5 Participants
|
27.17 units/d
STANDARD_DEVIATION 14.41 • n=7 Participants
|
31.94 units/d
STANDARD_DEVIATION 23.27 • n=5 Participants
|
|
Total Daily Dose Insulin
|
0.51 units/kg/d
STANDARD_DEVIATION 0.23 • n=5 Participants
|
0.48 units/kg/d
STANDARD_DEVIATION 0.23 • n=7 Participants
|
0.50 units/kg/d
STANDARD_DEVIATION 0.23 • n=5 Participants
|
|
Total Daily Dose Long-acting insulin only
|
18.50 units
STANDARD_DEVIATION 14.81 • n=5 Participants
|
14.14 units
STANDARD_DEVIATION 7.30 • n=7 Participants
|
16.26 units
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
puberty stage, tanner II-V
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months at 3 months intervalPopulation: individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.
Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.
Outcome measures
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Residual Beta-cell Function (RBCF)
Baseline
|
1.78 ng/ml
Standard Error 0.28
|
2.27 ng/ml
Standard Error 0.31
|
|
Residual Beta-cell Function (RBCF)
Mo 3
|
1.56 ng/ml
Standard Error 0.25
|
1.76 ng/ml
Standard Error 0.21
|
|
Residual Beta-cell Function (RBCF)
Mo 6
|
1.40 ng/ml
Standard Error 0.26
|
1.53 ng/ml
Standard Error 0.25
|
|
Residual Beta-cell Function (RBCF)
Mo 9
|
1.25 ng/ml
Standard Error 0.24
|
1.36 ng/ml
Standard Error 0.31
|
|
Residual Beta-cell Function (RBCF)
Mo 12
|
1.05 ng/ml
Standard Error 0.22
|
1.15 ng/ml
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsEffect of vitamin D supplementation on glycemic control during the partial clinical remission phase as shown by the change in percent HbA1c from baseline across longitudinal measurements at 0, 3, 6, 9, and 12 months.
Outcome measures
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Baseline
|
7.62 percent of HbA1C
Standard Error 0.32
|
7.47 percent of HbA1C
Standard Error 0.39
|
|
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Mo 3
|
7.25 percent of HbA1C
Standard Error 0.37
|
6.67 percent of HbA1C
Standard Error 0.28
|
|
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Mo 6
|
7.28 percent of HbA1C
Standard Error 0.27
|
7.15 percent of HbA1C
Standard Error 0.34
|
|
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Mo 9
|
7.48 percent of HbA1C
Standard Error 0.35
|
7.61 percent of HbA1C
Standard Error 0.32
|
|
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Mo 12
|
7.65 percent of HbA1C
Standard Error 0.57
|
8.03 percent of HbA1C
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline to 12 months at 3 months intervalPopulation: individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.
Investigation of the effect of vitamin D supplementation on GLP-1 during PCR.
Outcome measures
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Glucagon-like Peptide-1 (GLP-1)
Baseline
|
10.26 ng/ml
Standard Deviation 7.54
|
5.81 ng/ml
Standard Deviation 3.38
|
|
Glucagon-like Peptide-1 (GLP-1)
Mo 3
|
8.58 ng/ml
Standard Deviation 5.02
|
8.4 ng/ml
Standard Deviation 5.48
|
|
Glucagon-like Peptide-1 (GLP-1)
Mo 6
|
10.24 ng/ml
Standard Deviation 5.69
|
6.86 ng/ml
Standard Deviation 3.01
|
|
Glucagon-like Peptide-1 (GLP-1)
Mo 9
|
10.26 ng/ml
Standard Deviation 5.57
|
8.89 ng/ml
Standard Deviation 5.69
|
|
Glucagon-like Peptide-1 (GLP-1)
Mo 12
|
9.11 ng/ml
Standard Deviation 4.44
|
9.63 ng/ml
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Baseline to 12 months at 3 months intervalPopulation: individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.
Investigation of the effect of vitamin D supplementation on VDBP during PCR.
Outcome measures
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Vitamin D Binding Protein (VDBP)
Mo 9
|
135.79 ng/ml
Standard Deviation 38.47
|
131.51 ng/ml
Standard Deviation 38.86
|
|
Vitamin D Binding Protein (VDBP)
Mo 12
|
141.34 ng/ml
Standard Deviation 32.8
|
152.42 ng/ml
Standard Deviation 31.19
|
|
Vitamin D Binding Protein (VDBP)
Baseline
|
134.32 ng/ml
Standard Deviation 22.82
|
111.56 ng/ml
Standard Deviation 28.82
|
|
Vitamin D Binding Protein (VDBP)
Mo 3
|
118.11 ng/ml
Standard Deviation 27.93
|
118.79 ng/ml
Standard Deviation 22.96
|
|
Vitamin D Binding Protein (VDBP)
Mo 6
|
135.32 ng/ml
Standard Deviation 27.51
|
138.18 ng/ml
Standard Deviation 33.15
|
SECONDARY outcome
Timeframe: Baseline to12 months 3 monthlyPopulation: individuals aged 10 to 21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.
Insulin dose-adjusted hemoglobin A1c (HbA1c) (IDAA1C)
Outcome measures
| Measure |
Ergocalciferol
n=18 Participants
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 Participants
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Baseline
|
9.9 % of IDAA1c
Standard Error 0.4
|
9.4 % of IDAA1c
Standard Error 0.6
|
|
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Mo 3
|
9.7 % of IDAA1c
Standard Error 0.6
|
8.4 % of IDAA1c
Standard Error 0.4
|
|
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Mo 6
|
10.0 % of IDAA1c
Standard Error 0.5
|
9 % of IDAA1c
Standard Error 0.5
|
|
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Mo 9
|
10.4 % of IDAA1c
Standard Error 0.5
|
10.1 % of IDAA1c
Standard Error 0.5
|
|
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Mo 12
|
10.6 % of IDAA1c
Standard Error 0.6
|
10.7 % of IDAA1c
Standard Error 0.6
|
Adverse Events
Ergocalciferol
Serious events: 7 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ergocalciferol
n=18 participants at risk
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 participants at risk
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/18 • 12 months
|
5.6%
1/18 • 12 months
|
|
Endocrine disorders
Hyperglycemia
|
16.7%
3/18 • 12 months
|
5.6%
1/18 • 12 months
|
|
Endocrine disorders
mild hypoglycemia
|
16.7%
3/18 • 12 months
|
5.6%
1/18 • 12 months
|
|
Endocrine disorders
moderate hypoglycemia
|
5.6%
1/18 • 12 months
|
0.00%
0/18 • 12 months
|
Other adverse events
| Measure |
Ergocalciferol
n=18 participants at risk
Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Ergocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
|
Placebo
n=18 participants at risk
Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D
Placebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
5.6%
1/18 • 12 months
|
27.8%
5/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
mild hair loss
|
5.6%
1/18 • 12 months
|
0.00%
0/18 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place