NCT01075022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

February 23, 2010

Last Update Submit

February 23, 2010

Conditions

Insulin ResistanceGlucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose Level

    Baseline and day 90

Secondary Outcomes (2)

  • Blood Calcium Level

    Baseline and day 90

  • HOMA-R

    Baseline and day 90

Study Arms (2)

Vitamin D

EXPERIMENTAL
Drug: Colecalciferol (Vitamin D3) 300.000 UI

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Colecalciferol (Vitamin D3) 300.000 UIDRUG

Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose

Vitamin D
PlaceboDRUG

Placebo Capsule, Single Dose

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Insulin ResistanceGlucose Intolerance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Tania Furlanetto, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

May 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

BR(1)