Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
|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|
|Primary Completion Date :||June 2012|
|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.
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|