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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00320853
Enrollment
30
Registered
2006-05-03
Start date
2006-04-30
Completion date
2006-05-31
Last updated
2006-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Keywords

Diabetes, Vitamin D, Insulin sensitivity, Insulin secretion

Brief 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.

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.

Interventions

DRUGVitamin D

Sponsors

Sitaram Bhartia Institute of Science and Research
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
OGIS Index, Total Insulin Secretion

Secondary

MeasureTime frame
QUICKI
ISI composite
ISI stumvoll
ISI Gutt
HOMA
Lipid profile
CRP
ApoA1
ApoB
Insulinogenic Index

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026