search
Back to results

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

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
supplementation of 100.000 IU of vitamin D3
placebo pill
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, diabetes mellitus, vitamin D

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCPA, Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin D3

Placebo pill

Arm Description

supplementation of 100.000 IU of vitamin D3

Placebo

Outcomes

Primary Outcome Measures

Ambulatory Blood pressure monitoring
Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation

Secondary Outcome Measures

Full Information

First Posted
July 29, 2014
Last Updated
January 25, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
search

1. Study Identification

Unique Protocol Identification Number
NCT02204527
Brief Title
Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension
Official Title
Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, diabetes mellitus, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was a randomized, double-blind, placebo-controlled clinical trial on 40 outpatients with hypertension and type 2 diabetes were recruited. Patients were allocated into two equal groups of 20 by computer-generated randomly permutated codes. the subjects were randomly assigned to 1 of 2 groups: Group 1 received a single dose (100.000 IU) of oral supplementation with cholecalciferol (vitamin D3). Group 2 received matching placebo capsules containing microcrystalline cellulose.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D3
Arm Type
Experimental
Arm Description
supplementation of 100.000 IU of vitamin D3
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
supplementation of 100.000 IU of vitamin D3
Other Intervention Name(s)
supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)
Intervention Description
supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo pill
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Ambulatory Blood pressure monitoring
Description
Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
HCPA, Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33184328
Citation
de Paula TP, Moreira JSR, Sperb LF, Muller MEP, Steemburgo T, Viana LV. Efficacy of single-dose cholecalciferol in the blood pressure of patients with type 2 diabetes, hypertension and hypovitaminoses D. Sci Rep. 2020 Nov 12;10(1):19611. doi: 10.1038/s41598-020-76646-6.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs