Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
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|ClinicalTrials.gov Identifier: NCT01029392|
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Vitamin D||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||November 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Required Vitamin D
Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation
Drug: Vitamin D
2000iu once a day
Other Name: cholecalciferol
No Intervention: Normal Vitamin D
Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation
- Change in Hemoglobin A1c [ Time Frame: 6 months ]Change in hemoglobin A1c calculated as a percentage change from baseline measurement
- Change in Insulin Requirements [ Time Frame: 6 months ]Percentage change from baseline number of units of lantus insulin over 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029392
|United States, Michigan|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Peter Gerrits, MD||William Beaumont Hospitals|