Effects of cholecalciferol supplementation in peripheral blood leucocytes in patients with arterial hypertension, obesity and vitamin D deficiency.

Phase 1

• Conditions: Obesity associated arterial hypertensionMetabolic syndrome associated arterial hypertension; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-003910-26-PT
• Lead Sponsor: úcleo de Estudos de Hipertensão da Beira Interior

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Obtention of free and informed consent to participate, dated and signed by the participant
- Free willing and availability to participate in the all course of the trial as well as to accomplish with all the procedures of the trial protocol
- Hability to take autonomously oral medication and capacity to adhere to the therapeutic scheme proposed by the trial
- In women of child-bearing potential use of efficacious contraception
- Age between 45-65 years
- Treated essential hypertension (systolic blood pressure ¿ 159 mmHg and diastolic blood pressure ¿ 99 mmHg)
- Obesity (body mass index ¿ 30 Kg/m2) or metabolic syndrome by the International Diabetes Federation criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Actual or previous medication with modulatores of the immune system (e.g. steroids, immunossupressive medication)
- Actual treatment with antihistamines
- Autoimmmune disease
- Sarcoidosis
- Active infectious or neoplasic disease
- Other chronic infectious or inflammatory diseases (e.g. tuberculosis, diabetic foot, chronic viral hepatitis)
- Glomerular filtration rate < 60 mL/min/1,73m2
- Vitamin D in plasma VD ¿ 30 ng/mL
- Serum calcium > 10.5 mg/dL
- Kidney stones or nephrocalcinosis
- Active smoker
- Active treatment with cholecalciferol before the beggining of the trial
- Pregnacy, breastfeeding or non-utilization of efficacious contraceptive method
- Intolerance to cholecalciferol
- Simultaneous participation in another trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified