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Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01436916
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Prediabetes Vitamin D Deficiency Drug: oral cholecalciferol + life style counselling Drug: placebo + life style counselling Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
Study Start Date : September 2011
Primary Completion Date : September 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta % [ Time Frame: Base line and 6 months ]
  2. 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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01436916     History of Changes
Other Study ID Numbers: 0023051981
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 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