Cholecalciferol treatment to reduce blood pressure in older patients with isolated systolic hypertension: the VitDISH randomized controlled trial.
OBJECTIVE
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.


METHODS
Parallel group, double-blind, placebo-controlled randomized trial.


METHODS
Primary care clinics and hospital clinics.


METHODS
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.


METHODS
A total of 100,000 U of oral cholecalciferol or matching placebo every 3 months for 1 year.


METHODS
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
Vitamin D supplementation did not improve blood pressure or markers of vascular health in older patients with isolated systolic hypertension.


BACKGROUND
isrctn.org Identifier: ISRCTN92186858.
Miles D
MD
Witham
Rosemary J G
RJ
Price
Allan D
AD
Struthers
Peter T
PT
Donnan
Claudia-Martina
CM
Messow
Ian
I
Ford
Marion E T
ME
McMurdo
D000368:Aged; D001794:Blood Pressure / Q000187:drug effects*; D002762:Cholecalciferol / Q000008:administration & dosage*; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D013599:Systole; D016896:Treatment Outcome; D014815:Vitamins / Q000008:administration & dosage
D014815:Vitamins; D002762:Cholecalciferol