Phase 3
Completed N=75
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Source: ClinicalTrials.gov NCT01029392 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Change in Hemoglobin A1c — 2.67; 1.05 percentage change from baseline
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.
1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.
Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin requirements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c |
2.67; 1.05 | — |
| SECONDARY Change in Insulin Requirements |
2.62; 1.80 | — |
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed type I DM.
- Age <18 years
Exclusion Criteria
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01029392). 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. Informational only — not medical advice.