NCT01436916

Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.

Conditions

• Prediabetes
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	oral cholecalciferol + life style counselling	oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
DRUG	placebo + life style counselling	Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-09-20
• Last updated: 2015-10-26

Locations

1 site across 1 country: India