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

Hypertension Clinical Trial

Official title:

Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166165
• Other study ID #: EBP-TL-2010-2
• Secondary ID: M-20100120
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2010
• Last updated: June 18, 2012
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
3 tablets of 1000 IU daily for 20 weeks
• Placebo
3 placebo tablets daily for 20 weeks

Locations

Country	Name	City	State
Denmark	Department of Medical Research	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour systolic blood pressure		20 weeks	No
Secondary	Plasma renin concentration		20 weeks	No
Secondary	Plasma concentration of angiotensin II		20 weeks	No
Secondary	Plasma concentration of aldosterone		20 weeks	No
Secondary	Plasma concentration of c-reactive protein		20 weeks	No
Secondary	Urine albumin creatinine ratio		20 weeks	No
Secondary	Urine calcium creatinine ratio		20 weeks	No
Secondary	Plasma concentration of 25-hydroxycholecalciferol		5 weeks	No
Secondary	Serum concentration of FGF-23		20 weeks	No
Secondary	Augmentation index and central blood pressure		20 weeks	No
Secondary	Pulse wave velocity		20 weeks	No
Secondary	Heart rate variability		20 weeks	No
Secondary	Plasma concentration of ionized calcium		5 weeks	Yes
Secondary	Plasma concentration of phosphate		5 weeks	Yes