Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benjamin U. Nwosu, MD; University of Massachusetts, Worcester
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Massachusetts, Worcester
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Age: 10-21 years.

2. Sex: male and female subjects will be enrolled.

3. Tanner stage: I-V.

4. T1D duration of <3 months (i.e., from first insulin injection) to ensure the inclusion of patients in PCR.

5. Presence of at least one diabetes-associated autoantibody.

6. Normal-weight, overweight-, and obese subjects with T1D

7. Fasting serum C-peptide level 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:

1. Subjects on weight altering medications, such as orlistat.

2. Subjects with eating disorders

3. Subjects on medications other than insulin that can affect blood glucose level.

4. 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.

5. Subjects with systemic diseases other than T1D.

6. 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.

7. Pregnant or breast-feeding female subjects.

8. The receipt of any investigational drug within 6 months prior to this trial.

9. Active malignant neoplasm.