Cholecalciferol Treatment to Reduce Blood Pressure in Older Patients With Isolated Systolic Hypertension

Abstract

IMPORTANCE Observational data link low 25-hydroxyvitamin D levels to both prevalent blood pressure and incident hypertension. No clinical trial has yet examined the effect of vitamin D supplementation in isolated systolic hypertension, the most common pattern of hypertension in older people. OBJECTIVE To test whether high-dose, intermittent cholecalciferol supplementation lowers blood pressure in older patients with isolated systolic hypertension. DESIGN Parallel group, double-blind, placebo-controlled randomized trial. SETTING Primary care clinics and hospital clinics. PARTICIPANTS Patients 70 years and older with isolated systolic hypertension (supine systolic blood pressure >140 mm Hg and supine diastolic blood pressure <90 mm Hg) and baseline 25-hydroxyvitamin D levels less than 30 ng/mL were randomized into the trial from June 1, 2009, through May 31, 2011. INTERVENTIONS A total of 100 000 U of oral cholecalciferol or matching placebo every 3 months for 1 year. MAIN OUTCOMES AND MEASURES Difference in office blood pressure, 24-hour blood pressure, arterial stiffness, endothelial function, cholesterol level, insulin resistance, and b-type natriuretic peptide level during 12 months. RESULTS A total of 159 participants were randomized (mean age, 77 years). Mean baseline office systolic blood pressure was 163/78 mm Hg. Mean baseline 25-hydroxyvitamin D level was 18 ng/mL. 25-Hydroxyvitamin D levels increased in the treatment group compared with the placebo group (+8 ng/mL at 1 year, P < .001). No significant treatment effect was seen for mean (95% CI) office blood pressure (−1 [−6 to 4]/−2 [−4 to 1] mm Hg at 3 months and 1 [−2 to 4]/0 [−2 to 2] mm Hg overall treatment effect). No significant treatment effect was evident for any of the secondary outcomes (24-hour blood pressure, arterial stiffness, endothelial function, cholesterol level, glucose level, and walking distance). There was no excess of adverse events in the treatment group, and the total number of falls was nonsignificantly lower in the group receiving vitamin D (36 vs 46, P = .24). CONCLUSIONS AND RELEVANCE Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension.

Vitamin D and risk of CVD: a review of the evidence

“…However, 24 h ambulatory BP monitoring has been shown to be better at predicting cardiovascular risk compared with clinic BP (82,83) and the evidence has demonstrated that it is able to more accurately measure the size of reduction in BP brought about by a treatment compared with clinic BP, due to the results being more reproducible over time (84) , and the unlikelihood of a 'white coat' or placebo effect (82,85) . Only a few RCT have used 24 h ambulatory BP monitors (86)(87)(88)(89) (Table 1) and these were in participants who had hypertension (86,88,89) or had previously suffered from a stroke (87) . None showed a significant difference in the change in 24 h BP between treatment and placebo groups after treatment with 75 μgD 3 /d for 20 weeks (86) , a single oral dose of 2500 μg D 2 with 24 h BP measured after 16 weeks (87) , 2500 μg D 3 taken every 3 months for a year (88) or 2500 μg D 3 taken every 2 months for 6 months (89) .…”

“…Only a few RCT have used 24 h ambulatory BP monitors (86)(87)(88)(89) (Table 1) and these were in participants who had hypertension (86,88,89) or had previously suffered from a stroke (87) . None showed a significant difference in the change in 24 h BP between treatment and placebo groups after treatment with 75 μgD 3 /d for 20 weeks (86) , a single oral dose of 2500 μg D 2 with 24 h BP measured after 16 weeks (87) , 2500 μg D 3 taken every 3 months for a year (88) or 2500 μg D 3 taken every 2 months for 6 months (89) . There is a need for further well-conducted vitamin D RCT measuring 24 h ambulatory BP in healthy older participants.…”

Long-Term High-Dose Vitamin D 3 Supplementation and Blood Pressure in Healthy Adults

“…6 In only 6 of these studies is BP clearly identified as a primary end point. [10][11][12][13][14][15] Most randomized controlled trials gave vitamin D for periods <1 year (most <6 months) [10][11][12][13][16][17][18][19][20][21][22][23][24][25][26][27] and, therefore, are of limited use for addressing the efficacy of long-term vitamin D supplementation in preventing and treating hypertension. Only 7 trials of long-term (≥1 year) supplementation have been Abstract-Previous randomized controlled trials of vitamin D supplementation and blood pressure (BP) mainly have given vitamin D for short periods (<6 months) or at low doses (400 IU per day).…”

“…decrease <5 mm Hg) that would be of biological (if not clinical) significance. 15,28,30,31 Given these limitations, we decided to study the effect of long-term (18 months) high-dose vitamin D supplementation on BP. The present study was a prespecified secondary aim in a double-blind randomized controlled trial where the primary objective was to determine if vitamin D prevents upper respiratory tract infections.…”

Is Vitamin D a New Therapeutic Option in Coronary Artery Disease? Overview Data

“…Patients received 1000 IU/day of vitamin D3 or placebo for three months. In the group receiving vitamin D3, there was no significant effect of supplementation on blood pressure as well as on the 24-hour measurement of blood pressure, arterial stiffness, endothelial function, cholesterol and glucose [55].…”