Status:
COMPLETED
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Prediabetes
Vitamin D Deficiency
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01436916
Start Date
September 1 2011
End Date
December 1 2012
Last Update
October 26 2015
Active Locations (1)
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1
PGIMER
Chandigarh, Chandigarh(UT), India, 160012