Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension

January 25, 2017 updated by: Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre

Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension: Randomized Clinical Trial

In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D supplementation in patients with type 2 diabetes and hypertension

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
        • HCPA, Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes
  • hypovitaminosis D
  • hypertension

Exclusion Criteria:

  • pregnant or lactating
  • patients using vitamin D supplementation
  • using drugs that interfere on vitamin D metabolism (corticosteroids, anticonvulsants)
  • illicit drug use
  • diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl)
  • liver cirrhosis
  • alcoholism
  • dementia
  • malignant disease that compromises the 5-year survival,
  • digestive tract (malabsorption) diseases
  • BMI> 40 kg / m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D3
supplementation of 100.000 IU of vitamin D3
Dietary supplement: supplementation of 100.000 IU of vitamin D3
supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))
Other Names:
  • supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)
Placebo Comparator: Placebo pill
Placebo
Dietary supplement: placebo pill
Placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory Blood pressure monitoring
Time Frame: up to 24 hours
Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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