Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional health services research trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Type I, Newly Diagnosis Type I Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed type I DM.
- Age <18 years
Exclusion Criteria:
- Pregnancy
Sites / Locations
- WilliamBH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Required Vitamin D
Normal Vitamin D
Arm Description
Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation
Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1c
Change in hemoglobin A1c calculated as a percentage change from baseline measurement
Secondary Outcome Measures
Change in Insulin Requirements
Percentage change from baseline number of units of lantus insulin over 6 months.
Full Information
NCT ID
NCT01029392
First Posted
December 9, 2009
Last Updated
March 3, 2017
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01029392
Brief Title
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Official Title
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes, Type I, Newly Diagnosis Type I Diabetes Mellitus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients with clinically significantly low Vitamin D levels (<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Required Vitamin D
Arm Type
Experimental
Arm Description
Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation
Arm Title
Normal Vitamin D
Arm Type
No Intervention
Arm Description
Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Description
2000iu once a day
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
Change in hemoglobin A1c calculated as a percentage change from baseline measurement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Insulin Requirements
Description
Percentage change from baseline number of units of lantus insulin over 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed type I DM.
Age <18 years
Exclusion Criteria:
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gerrits, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
WilliamBH
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing.
Learn more about this trial
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
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