Effect of a Single Colecalciferol Dose on Insulin Resistance | NCT01075022

Studies
Effect of a Single Colecalciferol Dose on Insulin Resistance

NCT01075022

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Feb 24, 2010Estimated

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Insulin Resistance
Glucose Intolerance

Interventions

Colecalciferol (Vitamin D3) 300.000 UI
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jul 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2010

Last Update Posted Date

Feb 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Experimental		Drug: Colecalciferol (Vitamin D3) 300.000 UI
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colecalciferol (Vitamin D3) 300.000 UI	Drug	Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose	Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Glucose Level		Baseline and day 90

Secondary Outcomes

Measure	Description	Time Frame
Blood Calcium Level		Baseline and day 90
HOMA-R		Baseline and day 90

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fasten Blood Glucose > 100 mg/dL and < 126 mg/dL
Age > 18 years

Exclusion Criteria:

Diabetes Mellitus
Use of metformin
Vitamin D Use
Hypercalcemia
Chronic Hepatitis
HIV

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tania Furlanetto, PhD	Federal University of Rio Grande do Sul	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided