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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:
Information provided by:
Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier:
NCT00320853
First received: May 1, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   30 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00320853     History of Changes
Other Study ID Numbers: SBISR/2006/02
Study First Received: May 1, 2006
Last Updated: May 1, 2006
Health Authority: India: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014