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

Study Overview
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Brief Summary
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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

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

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: supplementation of 100.000 IU of vitamin D3
* Dietary Supplement: placebo pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3<br>supplementation of 100.000 IU of vitamin D3 | Dietary Supplement: supplementation of 100.000 IU of vitamin D3<br>* supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))<br>* Other names: supplementation of 100.000 IU of vitamin D3: Addera D3 (50.000IU each pill);|
| Placebo Comparator: Placebo pill<br>Placebo | Dietary Supplement: placebo pill<br>* Placebo<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, diabetes mellitus, vitamin D