Back to resultsEffect of a Single Colecalciferol Dose on Insulin Resistance
Primary Purpose
Insulin Resistance, Glucose Intolerance
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Colecalciferol (Vitamin D3) 300.000 UI
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
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
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Blood Glucose Level
Secondary Outcome Measures
Blood Calcium Level
HOMA-R
Full Information
NCT ID
NCT01075022
First Posted
February 23, 2010
Last Updated
February 23, 2010
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01075022
Brief Title
Effect of a Single Colecalciferol Dose on Insulin Resistance
Official Title
Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Glucose Intolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Colecalciferol (Vitamin D3) 300.000 UI
Intervention Description
Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsule, Single Dose
Primary Outcome Measure Information:
Title
Blood Glucose Level
Time Frame
Baseline and day 90
Secondary Outcome Measure Information:
Title
Blood Calcium Level
Time Frame
Baseline and day 90
Title
HOMA-R
Time Frame
Baseline and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Furlanetto, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
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Effect of a Single Colecalciferol Dose on Insulin Resistance
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