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Effect of a Single Colecalciferol Dose on Insulin Resistance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01075022
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Insulin Resistance
Glucose Intolerance
 Drug: Colecalciferol (Vitamin D3) 300.000 UI
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Blood Glucose Level [ Time Frame: Baseline and day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Calcium Level [ Time Frame: Baseline and day 90 ] [ Designated as safety issue: Yes ]
  • HOMA-R [ Time Frame: Baseline and day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: May 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D Drug: Colecalciferol (Vitamin D3) 300.000 UI
Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose
Placebo Comparator: Placebo Drug: Placebo
Placebo Capsule, Single Dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075022

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Tania Furlanetto, PhD Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Gustavo Faulhaber, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01075022     History of Changes
Other Study ID Numbers: 33598290
Study First Received: February 23, 2010
Last Updated: February 23, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013