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A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320853
First Posted: May 3, 2006
Last Update Posted: May 3, 2006
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.
Information provided by:
Sitaram Bhartia Institute of Science and Research
  Purpose
The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. 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.

Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent Drug: Vitamin D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by Sitaram Bhartia Institute of Science and Research:

Primary Outcome Measures:
  • OGIS Index, Total Insulin Secretion

Secondary Outcome Measures:
  • HOMA
  • QUICKI
  • ISI composite
  • ISI stumvoll
  • ISI Gutt
  • Insulinogenic Index
  • Lipid profile
  • CRP
  • ApoA1
  • ApoB

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: May 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00320853


Locations
India
Sitaram Bhartia Institute of Science and Research
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Sitaram Bhartia Institute of Science and Research
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 Director: Abhishek Bhartia, ME Sitaram Bhartia Institute of Science and Research
Study Chair: Anupama Singh, MD Sitaram Bhartia Institute of Science and Research
  More Information

ClinicalTrials.gov Identifier: NCT00320853     History of Changes
Other Study ID Numbers: SBISR/2006/02
First Submitted: May 1, 2006
First Posted: May 3, 2006
Last Update Posted: May 3, 2006
Last Verified: May 2006

Keywords provided by Sitaram Bhartia Institute of Science and Research:
Diabetes
Vitamin D
Insulin sensitivity
Insulin secretion

Additional relevant MeSH terms:
Diabetes Mellitus
Hypersensitivity
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Insulin
Vitamins
Vitamin D
Ergocalciferols
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents