NCT01166165CompletedPhase 2
Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
Regional Hospital Holstebro1 site in 1 country136 target enrollmentStarted: July 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- 24-hour systolic blood pressure
Study Overview
Brief Summary
High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Well-regulated arterial hypertension
- •Office blood pressure > 120/70 mmHg
Exclusion Criteria
- •Pregnancy or nursing
- •Alcohol abuse
- •Continuous glucocorticoid or NSAID treatment
- •24-hour blood pressure > 150/95 mmHg
- •Hypercalcemia
Arms & Interventions
Cholecalciferol
Active Comparator
Intervention: Cholecalciferol (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
24-hour systolic blood pressure
Time Frame: 20 weeks
Secondary Outcomes
- Plasma renin concentration(20 weeks)
- Plasma concentration of angiotensin II(20 weeks)
- Plasma concentration of aldosterone(20 weeks)
- Plasma concentration of c-reactive protein(20 weeks)
- Urine albumin creatinine ratio(20 weeks)
- Urine calcium creatinine ratio(20 weeks)
- Plasma concentration of 25-hydroxycholecalciferol(5 weeks)
- Serum concentration of FGF-23(20 weeks)
- Augmentation index and central blood pressure(20 weeks)
- Pulse wave velocity(20 weeks)
- Heart rate variability(20 weeks)
- Plasma concentration of ionized calcium(5 weeks)
- Plasma concentration of phosphate(5 weeks)
Investigators
Erling Bjerregaard Pedersen
DMSci
Regional Hospital Holstebro
Study Sites (1)
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