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

NCT03046927 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: H000105501R21DK113353
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; vitamin D; honeymoon phase

Outcome Measures

Primary Outcomes (1)

• Residual Beta-cell Function (RBCF)

  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.

  Baseline to 12 months at 3 months interval

Secondary Outcomes (4)

• Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)

  Baseline to 12 months

• Glucagon-like Peptide-1 (GLP-1)

  Baseline to 12 months at 3 months interval

• Vitamin D Binding Protein (VDBP)

  Baseline to 12 months at 3 months interval

• Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes

  Baseline to12 months 3 monthly

Study Arms (2)

Ergocalciferol

EXPERIMENTAL

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

Drug: Ergocalciferol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ergocalciferol DRUG

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

Also known as: Vitamin D

Ergocalciferol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 10-21 years.
• Sex: male and female subjects will be enrolled.
• Tanner stage: I-V.
• Presence of at least one diabetes-associated autoantibody.
• Normal-weight, overweight-, and obese subjects with T1D
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benjamin U. Nwosu, MD: lead
• University of Massachusetts, Worcester: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Benjamin U. Nwosu, MD
• Organization: University of Mass Medical

bnwosu1@northwell.edu

5083406936

Study Officials

• Benjamin U Nwosu, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ergocalciferol and placebo will be prepared as identical capsules by Boulevard Pharmaceutical Compounding Center. Randomization will be conducted by the Investigational Drug Services (IDS), UMMS, using a randomization scheme generated by Dr. Barton. Randomization will be 1:1 (ergocalciferol: placebo) and will use a permuted block design with blocking for every 2 or 4 subjects (at random). IDS will maintain blinding information and PI will contact IDS for emergency unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 12-month randomized, double-blind, placebo-controlled, parallel design trial

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 8, 2017
• Study Start: October 19, 2017
• Primary Completion: April 12, 2021
• Study Completion: April 20, 2021
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)