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

Regional Hospital Holstebro

Status and phase: Completed; Phase 2

Conditions: Hypertension; Vitamin D Deficiency

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01166165

EBP-TL-2010-2

M-20100120 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

Cholecalciferol

Active Comparator group

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo