- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320853
A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion
A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.
Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110016
- Sitaram Bhartia Institute of Science and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- ≥30 years of age
- Waist circumference ≥80 cm
Exclusion Criteria:
- Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
- BP>140/90 or on anti-hypertensive medication
- Receiving Vitamin D or calcium supplementation
- Chronic disease-renal/hepatic/malignancy/gastrointestinal
- On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
- Febrile illness or infective morbidity in the past 10 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
OGIS Index, Total Insulin Secretion
|
Secondary Outcome Measures
Outcome Measure |
---|
Lipid profile
|
CRP
|
HOMA
|
ApoA1
|
ApoB
|
QUICKI
|
ISI composite
|
ISI stumvoll
|
ISI Gutt
|
Insulinogenic Index
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jitendra N Pande, MD, Sitaram Bhartia Institute of Science and Research
- Principal Investigator: Jitender Nagpal, MD, Sitaram Bhartia Institute of Science and Research
- Study Chair: Anupama Singh, MD, Sitaram Bhartia Institute of Science and Research
- Study Director: Abhishek Bhartia, ME, Sitaram Bhartia Institute of Science and Research
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBISR/2006/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Non-Insulin-Dependent
-
VeraLight, Inc.CompletedDiabetes Mellitus, Non-Insulin DependentUnited States
-
Procter and GambleTerminatedNon-Insulin-dependent Diabetes MellitusUnited States
-
Inha University HospitalCompletedNon Insulin Dependent Diabetes MellitusKorea, Republic of
-
VeraLight, Inc.CompletedDiabetes Mellitus, Non-Insulin DependentUnited States
-
National Center for Complementary and Integrative...CompletedDiabetes Mellitus, Non-Insulin Dependent | Non-Insulin DependentUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedDiabetes Mellitus, Type II | Diabetes Mellitus, Non Insulin DependentUnited States, Poland, Bulgaria, India, Malaysia, Romania, Canada, Russian Federation, Argentina, Puerto Rico, Czech Republic, United Kingdom, Mexico
-
Merck Sharp & Dohme LLCCompletedDiabetes Mellitus, Non-Insulin-Dependent | Type 2 Diabetes Mellitus, Non Insulin Dependent
-
National Nutrition and Food Technology InstituteCompletedNon Insulin Dependent DiabetesIran, Islamic Republic of
-
Lille Catholic UniversityUniversity Hospital, LilleTerminatedNon-insulin-dependent DiabetesFrance
-
National Nutrition and Food Technology InstituteUnknownNon Insulin Dependent DiabetesIran, Islamic Republic of
Clinical Trials on Vitamin D
-
PfizerTerminated
-
Umeå UniversityRegion SkaneCompleted
-
Fundación Cardiovascular de ColombiaUniversidad Industrial de Santander; Farma de Colombia SACompletedVitamin D Deficiency | Overweight and Obesity | Overweight AdolescentsColombia
-
Khon Kaen UniversityNot yet recruiting
-
Nutrition Institute, SloveniaSlovenian Research Agency; Higher School of Applied Sciences (VIST); Valens Int...CompletedVitamin D DeficiencySlovenia
-
USDA, Western Human Nutrition Research CenterCompletedVitamin D DeficiencyUnited States
-
University of AarhusNot yet recruitingImmune System Diseases | Growth | Child Development | Vitamin D Supplementation
-
University Hospital, Basel, SwitzerlandCompleted
-
Cornell UniversityArogyavaram Medical CentreNot yet recruiting
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting