Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

NCT ID: NCT01436916

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

oral cholecalciferol + lifestyle counselling

will receive Oral cholecalciferol

Group Type: ACTIVE_COMPARATOR

oral cholecalciferol + life style counselling

Intervention Type: DRUG

oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months

Placebo + lifestyle counselling

will receive placebo

Group Type: PLACEBO_COMPARATOR

placebo + life style counselling

Intervention Type: DRUG

Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Interventions

oral cholecalciferol + life style counselling

oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months

Intervention Type: DRUG

placebo + life style counselling

Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Anil Bhansali

professor and head of the department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Bhansali, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

PGIMER

Chandigarh, Chandigarh(UT), India

Countries

India

Other Identifiers

0023051981

Identifier Type: -

Identifier Source: org_study_id