Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

Phase 2

Completed

• Conditions: Hypertension; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol; Drug: Placebo

• Registration Number: NCT01166165
• Lead Sponsor: Regional Hospital Holstebro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Well-regulated arterial hypertension
• Office blood pressure > 120/70 mmHg

Exclusion Criteria

• Pregnancy or nursing
• Cancer
• Alcohol abuse
• Continuous glucocorticoid or NSAID treatment
• 24-hour blood pressure > 150/95 mmHg
• Hypercalcemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
24-hour systolic blood pressure	20 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Medical Research; 🇩🇰 Holstebro, Denmark