Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements

Phase 3

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Vitamin D

• Registration Number: NCT01029392
• Lead Sponsor: William Beaumont Hospitals

Brief 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.

Detailed Description

New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of \<30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-12
• Results First Submitted: 2016-12-13
• Results First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Newly diagnosed type I DM.
• Age <18 years

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Required Vitamin D	Vitamin D	Those children whose Vitamin D level was low (\<30 ng/mL) are given Vitamin D supplementation

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	6 months	Change in hemoglobin A1c calculated as a percentage change from baseline measurement

Secondary Outcome Measures

Name	Time	Method
Change in Insulin Requirements	6 months	Percentage change from baseline number of units of lantus insulin over 6 months.

Trial Locations

Locations (1)

WilliamBH; 🇺🇸 Royal Oak, Michigan, United States