NCT00320853

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
Last Updated

May 3, 2006

Status Verified

May 1, 2006

First QC Date

May 1, 2006

Last Update Submit

May 1, 2006

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Keywords

DiabetesVitamin DInsulin sensitivityInsulin secretion

Outcome Measures

Primary Outcomes (1)

  • OGIS Index, Total Insulin Secretion

Secondary Outcomes (10)

  • HOMA

  • QUICKI

  • ISI composite

  • ISI stumvoll

  • ISI Gutt

  • +5 more secondary outcomes

Interventions

Vitamin DDRUG

Eligibility Criteria

Age30 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • ≥30 years of age
  • Waist circumference ≥80 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

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 2Diabetes MellitusInsulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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

  • Abhishek Bhartia, ME

    Sitaram Bhartia Institute of Science and Research

    STUDY DIRECTOR

  • Anupama Singh, MD

    Sitaram Bhartia Institute of Science and Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

April 1, 2006

Study Completion

May 1, 2006

Last Updated

May 3, 2006

Record last verified: 2006-05

Locations

IN(1)