Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436916
• Other study ID #: 0023051981
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: October 23, 2015
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adults > 20 years

• Impaired fasting glucose (IFG) - FPG 100-125 mg/dl

• Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl

OR

• both ( IFG +IGT)

• with or without Hb A1c -5.7-6.4 %

WITH

• Asymptomatic Vitamin D deficiency(< 20ng/ml) or vitamin D in sufficiency(< 32ng/ml)

Exclusion Criteria:

• Diabetes mellitus,

• Base line 25(OH)D3 > 32 ng/ml,

• Symptomatic vitamin D deficiency,

• Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism

• Chronic renal , hepatic ,malignant, intestinal or endocrine diseases

• Febrile illness or infective morbidity in last 2 weeks,

• Grossly deranged liver and kidney function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Vitamin D Deficiency

Intervention

Drug:
• oral cholecalciferol + life style counselling
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
• placebo + life style counselling
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Locations

Country	Name	City	State
India	PGIMER	Chandigarh	Chandigarh(UT)

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)		Base line and 6 months	No
Secondary	change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %		Base line and 6 months	No
Secondary	change in other insulin sensitivity indices	QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices	Base line and 6 months	No
Secondary	Change in Hb A1c		Base line and 6 months	No
Secondary	Change in fasting and post prandial blood glucose		0,3, 6months	No