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Study of Vitamin D and Statins on Vascular Function in hypertensive patients

Study of Vitamin D and 3-Hidroximetilglutaril CoA redutase inhibitors administration on Endothelial Function and Renin-Angiotensin-Aldosterone system in patients with Hypertension: a double-blind placebo-controlled study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-2zx53z
Enrollment
Unknown
Registered
2018-08-21
Start date
2016-07-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Cardiac and renal hypertensive disease, non specified

Interventions

80 patients will be recruited e divided by 4 groups of intervention: Group 1: 20 patients will receive 40mg of Simvastatin per oral daily and 100.000 units of 25-OH Vitamin D (Cholecalciferol) - 10 dr
Drug
G02.111.570.080.689.330.700.920
A07.231.700.500
D12.644.456.073.070

Sponsors

Unifesp - Universidade Federal de São Paulo
Lead Sponsor
SBIAE - Sociedade Beneficente Israelita Brasileira Albert Einstein
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Volunteers with essential hypertension, without hypertension related organ damage. Between 18 and 75 years old.

Exclusion criteria

Exclusion criteria: Patients previously with: Diabetes mellitus; Autoimunne disease; Neurologic Degenerative disease; Calcium or phosphate metabolism disease; Clinical need of lipid lowering drug prescription. Beside these: Patients who refuse to sign in voluntary consent letter; Patients with severe Hypertension (Sys > 180mmHg / Dias >110mmHg); Patients with hypertensive organ related damage or patients with secundary hypertension diagnosis.

Design outcomes

Primary

MeasureTime frame
Reduction of the value of the ADMA (Asymmetric Dimethyl Arginine ) compared to the baseline value (pre-treatment) of about 30% as measured by the HPLC method (high perfomance liquid chromatography)

Secondary

MeasureTime frame
Reduction of the expression of inflammatory markers - Tumor necrosis factor in about 15% in cultures of cells treated with the serum of the patients of each intervention arm measured by real time PCR;Reduction of Angiotensin 2 expression by about 15% in cultures of cells treated with patient serum from each intervention arm by ELISA protocol

Countries

Brazil

Contacts

Public ContactMarcelo;Paulo Ricardo Batista;Lins

Unifesp - Universidade Federal de São Paulo;Unifesp - Universidade Federal de São Paulo

mcbatista@uol.com.br;pr.lins@uol.com.br+55-011-982792696;+55-011-982792696

Outcome results

None listed

Source: REBEC (via WHO ICTRP)