Role Of Oral Cholecalciferol As Adjuvant Therapy In Type 1 Diabetes Mellitus: Randomized Controlled Trial (#313)
Introduction:
The vitamin D hormone system has been implicated in the pathogenesis of several autoimmune diseases, including Type 1 Diabetes Mellitus, as an adaptive immune system modulator.
Objectives
The objective of this study is to examine the role of cholecalciferol in modulating the altered immune response in T1DM, thereby improving glycemic control and residual pancreatic Beta-cell function, measured objectively by Hemoglobin A1c levels, GAD65 antibody titers and C-peptide levels.
Method
52 T1DM patients aged 1-18 years attending JIPMER Pediatrics department in year 2014 were randomized into two groups. High dose oral cholecalciferol therapy (1.2 lakh IU per month) was instituted in addition to insulin in intervention arm, while only insulin was continued in other arm for 6 months.
Results
Prevalence of Vitamin D deficiency was as high as 63.5% among T1DM patients in our study. High dose oral cholecalciferol supplementation caused significant rise in serum vitamin D levels to sufficient range in Cholecalciferol group. The Cholecalciferol group achieved significantly lower HbA1c levels at 3 and 6 months follow-up than controls ( p<0.05). The mean C-peptide levels were significantly greater (p <0.05) and mean GAD65 antibody levels were significantly lower (p<0.01) for cholecalciferol group as compared to controls at end of 6 months. No adverse events due to cholecalciferol therapy were reported.
Conclusions
Our study shows that high dose oral Cholecalciferol concomitant with insulin therapy is safe and is related to protective immunologic profile and slow decline of residual