Phase 3
N=36
Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03046927 ↗Enrolled (actual)
36
Serious AEs
27.8%
Results posted
Jul 2024
Primary outcome: Primary: Residual Beta-cell Function (RBCF) — 1.78; 2.27; 1.56; 1.76 ng/ml — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ergocalciferol (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Benjamin U. Nwosu, MD
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Beta-cell Function (RBCF) |
1.78; 2.27; 1.56; 1.76; 1.40; 1.53 | <0.001 sig |
| SECONDARY Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR) |
7.62; 7.47; 7.25; 6.67; 7.28; 7.15 | <0.01 sig |
| SECONDARY Glucagon-like Peptide-1 (GLP-1) |
10.26; 5.81; 8.58; 8.4; 10.24; 6.86 | 0.0241 sig |
| SECONDARY Vitamin D Binding Protein (VDBP) |
134.32; 111.56; 118.11; 118.79; 135.32; 138.18 | 0.23 |
| SECONDARY Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes |
9.9; 9.4; 9.7; 8.4; 10.0; 9 | <0.001 sig |
Summary
This project is designed to study the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment. The results could lead to significant changes in the approach to the early phase of type 1 diabetes with a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these patients on a standardized insulin regimen. The overall goal is to reduce the long-term complications of type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
- Age: 10-21 years.
- Sex: male and female subjects will be enrolled.
- Tanner stage: I-V.
- T1D duration of 0.1 nmol/L (0.3 ng/mL)1; or 2-hour post-meal stimulated C-peptide level of 0.2 nmol/L (≥0.6 ng/mL).
Exclusion Criteria
- Subjects on weight altering medications, such as orlistat.
- Subjects with eating disorders
- Subjects on medications other than insulin that can affect blood glucose level.
- Subjects with 25-hydroxyvitamin D [25(OH)D] levels of >70 ng/mL, as this may lead to vitamin D toxicity in the study subjects.
- Subjects with systemic diseases other than T1D.
- Subjects with recurrent diabetic ketoacidosis (>2 episodes since the diagnosis of T1D or in the preceding 3 months); or >2 episodes of severe hypoglycemia in the preceding 3 mo.
- Pregnant or breast-feeding female subjects.
- The receipt of any investigational drug within 6 months prior to this trial.
- Active malignant neoplasm.
Data sourced from ClinicalTrials.gov (NCT03046927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.