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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320853
• Other study ID #: SBISR/2006/02
• Status: Completed
• Phase: N/A
• First received: May 1, 2006
• Last updated: May 1, 2006
• Start date: April 2006
• Est. completion date: May 2006

Study information

• Verified date: May 2006
• Source: Sitaram Bhartia Institute of Science and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Drug:
• Vitamin D

Locations

Country	Name	City	State
India	Sitaram Bhartia Institute of Science and Research	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sitaram Bhartia Institute of Science and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OGIS Index, Total Insulin Secretion
Secondary	HOMA
Secondary	QUICKI
Secondary	ISI composite
Secondary	ISI stumvoll
Secondary	ISI Gutt
Secondary	Insulinogenic Index
Secondary	Lipid profile
Secondary	CRP
Secondary	ApoA1
Secondary	ApoB