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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02204527

Enrollment

Registered

2014-07-30

Start date

2015-10-31

Completion date

2016-12-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, diabetes mellitus, vitamin D

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

Interventions

DIETARY_SUPPLEMENTsupplementation of 100.000 IU of vitamin D3

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

DIETARY_SUPPLEMENTplacebo pill

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026