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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Vitamin D
Ergocalciferols
Vitamins
Insulin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 21, 2014