NCT00347542

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

June 30, 2006

Last Update Submit

May 31, 2013

Conditions

Diabetes Mellitus, Non-Insulin-DependentObesity

Keywords

Vitamin DDiabetesInsulin sensitivityObesity

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Insulin Sensitivity (OGIS)

Secondary Outcomes (5)

  • Lipid profile

  • CRP

  • ApoA1

  • ApoB

  • Blood Pressure

Interventions

Vitamin DDRUG

Eligibility Criteria

Age35 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sitaram Bhartia Institute of Science and Research

New Delhi, National Capital Territory of Delhi, 110016, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes MellitusInsulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jitendra N Pande, MD

    Sitaram Bhartia Institute of Science and Research

    PRINCIPAL INVESTIGATOR

  • Jitender Nagpal, MD

    Sitaram Bhartia Institute of Science and Research

    PRINCIPAL INVESTIGATOR

  • Anupama Singh, MD

    Sitaram Bhartia Institute of Science and Research

    STUDY CHAIR

  • Abhishek Bhartia, ME

    Sitaram Bhartia Institute of Science and Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Jitender Nagpal

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

IN(1)