Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D
Status: | Archived |
---|---|
Conditions: | Gastrointestinal, Diabetes |
Therapuetic Areas: | Endocrinology, Gastroenterology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | November 2009 |
End Date: | June 2012 |
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials