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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014