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Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

This study has been completed.
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research Identifier:
First received: September 13, 2011
Last updated: October 23, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Vitamin D Deficiency
Drug: oral cholecalciferol + life style counselling
Drug: placebo + life style counselling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency

Resource links provided by NLM:

Further study details as provided by Anil Bhansali, Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) [ Time Frame: Base line and 6 months ]

Secondary Outcome Measures:
  • change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta % [ Time Frame: Base line and 6 months ]
  • change in other insulin sensitivity indices [ Time Frame: Base line and 6 months ]
    QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices

  • Change in Hb A1c [ Time Frame: Base line and 6 months ]
  • Change in fasting and post prandial blood glucose [ Time Frame: 0,3, 6months ]

Enrollment: 50
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral cholecalciferol + lifestyle counselling
will receive Oral cholecalciferol
Drug: oral cholecalciferol + life style counselling
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
Placebo Comparator: Placebo + lifestyle counselling
will receive placebo
Drug: placebo + life style counselling
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults > 20 years
  • Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
  • Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl


  • both ( IFG +IGT)
  • with or without Hb A1c -5.7-6.4 %


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01436916

Chandigarh, Chandigarh(UT), India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Principal Investigator: Anil Bhansali, MD, DM Postgraduate Institute of Medical Education and Research
  More Information

Responsible Party: Anil Bhansali, professor and head of the department of Endocrinology, Postgraduate Institute of Medical Education and Research Identifier: NCT01436916     History of Changes
Other Study ID Numbers: 0023051981
Study First Received: September 13, 2011
Last Updated: October 23, 2015

Keywords provided by Anil Bhansali, Postgraduate Institute of Medical Education and Research:
oral cholecalciferol

Additional relevant MeSH terms:
Vitamin D Deficiency
Prediabetic State
Glucose Intolerance
Deficiency Diseases
Nutrition Disorders
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017