Clinical trial NCT00320853: A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion
Official title: A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Diabetes
Vitamin D
Insulin sensitivity
Insulin secretion
Lead sponsor: Sitaram Bhartia Institute of Science and Research
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 30
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: OGIS Index, Total Insulin Secretion
Secondary outcomes:
measure: HOMA
measure: QUICKI
measure: ISI composite
measure: ISI stumvoll
measure: ISI Gutt
measure: Insulinogenic Index
measure: Lipid profile
measure: CRP
measure: ApoA1
measure: ApoB
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sitaram Bhartia Institute of Science and Research
state: Delhi
Study officials:
affiliation: Sitaram Bhartia Institute of Science and Research
name: Jitendra N Pande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Jitender Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Abhishek Bhartia, ME
role: STUDY_DIRECTOR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Anupama Singh, MD
role: STUDY_CHAIR
References: