NCT01436916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

September 13, 2011

Last Update Submit

October 23, 2015

Conditions

PrediabetesVitamin D Deficiency

Keywords

prediabetesoral cholecalciferol

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)

    Base line and 6 months

Secondary Outcomes (4)

  • change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %

    Base line and 6 months

  • change in other insulin sensitivity indices

    Base line and 6 months

  • Change in Hb A1c

    Base line and 6 months

  • Change in fasting and post prandial blood glucose

    0,3, 6months

Study Arms (2)

oral cholecalciferol + lifestyle counselling

ACTIVE COMPARATOR

will receive Oral cholecalciferol

Drug: oral cholecalciferol + life style counselling

Placebo + lifestyle counselling

PLACEBO COMPARATOR

will receive placebo

Drug: placebo + life style counselling

Interventions

oral cholecalciferol + life style counsellingDRUG

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

oral cholecalciferol + lifestyle counselling
placebo + life style counsellingDRUG

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

Placebo + lifestyle counselling

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Chandigarh(UT), 160012, India

Location

MeSH Terms

Conditions

Prediabetic StateVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Anil Bhansali, MD, DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor and head of the department of Endocrinology

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 20, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

October 26, 2015

Record last verified: 2015-10

Locations

IN(1)