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Trial record 96 of 2488 for:    hyperinsulinism
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Effect of a Single Colecalciferol Dose on Insulin Resistance

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ClinicalTrials.gov Identifier: NCT01075022
Recruitment Status : Unknown
Verified February 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Enrolling by invitation
First Posted : February 24, 2010
Last Update Posted : February 24, 2010
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Glucose Intolerance Drug: Colecalciferol (Vitamin D3) 300.000 UI Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial
Study Start Date : May 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Blood Glucose Level [ Time Frame: Baseline and day 90 ]

Secondary Outcome Measures :
  1. Blood Calcium Level [ Time Frame: Baseline and day 90 ]
  2. HOMA-R [ Time Frame: Baseline and day 90 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Gustavo Faulhaber, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01075022     History of Changes
Other Study ID Numbers: 33598290
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010

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