A randomized placebo-controlled trial to investigate blood pressure lowering effects of folic acid in patients with borderline hypertension.
- Conditions
- Patients with hyperhomocysteinemia and high-normal blood pressure, otherwise healthy
- Registration Number
- EUCTR2005-000333-38-DE
- Lead Sponsor
- Organisation name was not entered
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients with hyperhomocysteinemia and high normal systolic (> 135mmHg) and/or diastolic (>85mmHg) blood pressure
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Smoker (> 5/d), alcoholism, high coffee or tee consumption (>500ml/d), obesity (BMI >30kg/m²), hypertension that need to be treated or allredy treated, suspected or known secondary origin of hypertension, high LDL-Cholesterol (>160mg/dl), diabetes mellitus, megaloblast anemia, regular medication (with exception of oral anticontraception) or vitamin substitution, participation in an other clinical trial within the last 4 weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Proof of effectivenes to reduce a high-normal blood pressure by supplementation of folic acid 5mg in persons with hyperhomocysteinemia.;Secondary Objective: Correlation of blood pressure reduction with reduction of hyperhomocysteinemia;Primary end point(s): Reduction of systolic blood pressure after supplementation of 5mg folic acid for 8 weeks as compared to placebo (substudy A).<br>Reduction of diastolic blood pressure after supplementation of 5mg folic acid for 8 weeks as compared to placebo (substudy B).
- Secondary Outcome Measures
Name Time Method