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CompletedNCT00347542Updated Jun 3, 2013

A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men

An interventional study of Vitamin D in Diabetes Mellitus, Non-Insulin-Dependent and Obesity, sponsored by Sitaram Bhartia Institute of Science and Research. Completed at 1 site in India. Open to male participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-03.

Sponsored by Sitaram Bhartia Institute of Science and Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years and older
Sex
Male
01

Study summary

The purpose of the study is to evaluate the change in glucose and insulin metabolism(early markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

Read the 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.These results have been replicated in patients at risk for diabetes with documentation of impairment in insulin secretion in Vitamin D deficient subjects. Therefore, vitamin D could be implicated in the pathogenesis of type 2 diabetes, by affecting either insulin sensitivity or ß cell function, or both. However, there is paucity of literature on the effect of Vitamin D supplementation on insulin resistance or glucose metabolism. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.

02

Conditions studied

  • Diabetes Mellitus, Non-Insulin-Dependent
  • Obesity

Keywords

  • Vitamin D
  • Diabetes
  • Insulin sensitivity
  • Obesity
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sitaram Bhartia Institute of Science and Research is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • ≥35 years of age
  • Waist circumference ≥78 cm

Exclusion criteria

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
  • Past history of nephrolithiasis
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
100 participants

Interventions

  • DrugVitamin D
06

What researchers measure

Primary outcomes

  1. Oral Glucose Insulin Sensitivity (OGIS)

Secondary outcomes

  1. Lipid profile

  2. CRP

  3. ApoA1

  4. ApoB

  5. Blood Pressure

07

Study locations

1 site
  • Sitaram Bhartia Institute of Science and Research
    New Delhi, Delhi 110016, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00347542
Lead sponsor
Sitaram Bhartia Institute of Science and Research
Responsible party
Dr Jitender Nagpal (Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research) — Principal investigator
First posted
Jul 4, 2006
Start date
Jul 2006
Primary completion
Sep 2007
Completion
Oct 2007
Last update
Jun 3, 2013

Study contacts

Jitendra N Pande, MD
principal investigator · Sitaram Bhartia Institute of Science and Research
Jitender Nagpal, MD
principal investigator · Sitaram Bhartia Institute of Science and Research
Anupama Singh, MD
study chair · Sitaram Bhartia Institute of Science and Research
Abhishek Bhartia, ME
study director · Sitaram Bhartia Institute of Science and Research
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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