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Vitamin D therapy in individuals with prehypertension or hypertension: the DAYLIGHT trial.

Circulation (2014-11-02)
Pankaj Arora, Yanna Song, Jeffery Dusek, Gregory Plotnikoff, Marc S Sabatine, Susan Cheng, Andre Valcour, Heather Swales, Beth Taylor, Erin Carney, Derek Guanaga, Joseph R Young, Courtney Karol, Michael Torre, Atum Azzahir, Semerit M Strachan, Dillon C O'Neill, Myles Wolf, Frank Harrell, Christopher Newton-Cheh, Thomas J Wang
ABSTRACT

A large body of epidemiological and experimental evidence suggests that vitamin D deficiency may promote hypertension. This raises the possibility that vitamin D supplementation could be a simple intervention to reduce blood pressure, but data from prospective, randomized trials are limited. A double-blind, randomized, controlled trial was conducted at 4 sites in the United States. We enrolled 534 individuals 18 to 50 years of age with low vitamin D status (25-hydroxyvitamin D levels ≤25 ng/mL) and systolic blood pressure of 120 to 159 mm Hg. Participants were randomized to high-dose (4000 IU/d) versus low-dose (400 IU/d) oral vitamin D3 for 6 months. The primary end point was change in mean 24-hour systolic blood pressure. Secondary end points included change in ambulatory diastolic blood pressure and clinic systolic and diastolic blood pressures. The median age was 38 years, and 62% of participants were men. Forty-six percent of participants were white, and 48% were black. The median 25-hydroxyvitamin D level at baseline was 15.3 ng/mL. Four-hundred fifty-five participants (85%) had at least 1 follow-up blood pressure measurement; 383 participants (72%) completed the full 6-month study. At the end of the study, there was no significant difference in the primary end point (change in mean 24-hour systolic blood pressure, -0.8 versus -1.6 mm Hg in the high-dose and low-dose arms; P=0.71) or in any of the secondary end points. Furthermore, there was no evidence of association between change in 25-hydroxyvitamin D and change in 24-hour systolic blood pressure at 6 months (Spearman correlation coefficient, -0.05, P=0.34). Results were consistent across prespecified subgroups. Vitamin D supplementation did not reduce blood pressure in individuals with prehypertension or stage I hypertension and vitamin D deficiency. Our findings suggest that the association between vitamin D status and elevated blood pressure noted in observational studies is not causal. http://www.clinicaltrials.gov. Unique identifier: NCT01240512.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Cholecalciferol, ≥98% (HPLC)
Supelco
Cholecalciferol (Vitamin D3), Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Vitamin D3 solution, 1 mg/mL in ethanol, ampule of 1 mL, certified reference material, Cerilliant®
Supelco
Cholecalciferol (D3), analytical standard
USP
Cholecalciferol, United States Pharmacopeia (USP) Reference Standard
Cholecalciferol, European Pharmacopoeia (EP) Reference Standard
Cholecalciferol for system suitability, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Cholecalciferol, meets USP testing specifications
Sigma-Aldrich
Cholecalciferol, analytical standard