CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 enrolled
Drug / intervention
Ergocalciferol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03046927
NCT03046927Phase 3Completed

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

Benjamin U. Nwosu, MD·interventional·Posted Feb 8, 2017·Updated Jul 10, 2024

In Brief

A Phase 3 clinical trial evaluating Ergocalciferol and Placebo for Type 1 Diabetes. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartOct 19, 2017
Primary CompletionApr 12, 2021
Study CompletionApr 20, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.4 years ago

Interventions

Ergocalciferoldrug

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

Placeboother

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