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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204527
• Other study ID #: 140415
• Status: Terminated
• Phase: N/A
• First received: July 29, 2014
• Last updated: January 25, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• supplementation of 100.000 IU of vitamin D3
supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))
• placebo pill
Placebo

Locations

Country	Name	City	State
Brazil	HCPA, Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Blood pressure monitoring	Blood pressure will be assessed by Ambulatory Blood Pressure Monitoring before and after vitamin D supplementation	up to 24 hours