Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension
NCT ID: NCT02204527
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2015-10-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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vitamin D3
supplementation of 100.000 IU of vitamin D3
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
placebo pill
Placebo
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hypovitaminosis D
* hypertension
Exclusion Criteria
* 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
30 Years
80 Years
ALL
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Mirela Jobim de Azevedo
Mirela Jobim Azevedo
Locations
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HCPA, Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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References
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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.
Other Identifiers
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140415
Identifier Type: -
Identifier Source: org_study_id
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