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

NCT02204527 | Terminated DMC

• 1 other identifier: 140415
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

hypertension; diabetes mellitus; vitamin D

Outcome Measures

Primary Outcomes (1)

• Ambulatory Blood pressure monitoring

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

  up to 24 hours

Study Arms (2)

vitamin D3

EXPERIMENTAL

supplementation of 100.000 IU of vitamin D3

Dietary Supplement: supplementation of 100.000 IU of vitamin D3

Placebo pill

PLACEBO COMPARATOR

Placebo

Dietary Supplement: placebo pill

Interventions

supplementation of 100.000 IU of vitamin D3 DIETARY_SUPPLEMENT

supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))

Also known as: supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill)

vitamin D3

placebo pill DIETARY_SUPPLEMENT

Placebo

Also known as: Placebo

Placebo pill

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes
• hypovitaminosis D
• hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

HCPA, Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33184328 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mirela Jobim Azevedo

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 30, 2014
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

BR (1)