A randomized controlled trial of high-dose vitamin D3 in patients with heart failure

Rebecca S. Boxer, Anne M. Kenny, Brian J. Schmotzer, Marianne Vest, Justin J. Fiutem, Ileana L. Pina

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Objectives: The aim of this study was to investigate the effect of vitamin D3 on physical performance in patients with heart failure (HF). Background: HF is associated with functional decline and frailty. Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF. Methods: Sixty-four patients participated in a 6-month parallel-design, double-blind randomized controlled trial to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly; all patients received daily calcium. Patients were included, regardless of ejection fraction, if they had 25 hydroxyvitamin D (25[OH]D) levels ≤37.5 ng/ml. The primary outcome was peak oxygen uptake, and secondary outcomes were 6-min walk distance, timed get up and go, and knee isokinetic muscle strength. Between-group comparisons were made using analysis-of-covariance models that adjusted for baseline measures. Results: Patients' mean age was 65.9 ± 10.4 years, 48% were women, 64% were African American, the mean ejection fraction was 37.6 ± 13.9%, 36% were in New York Heart Association functional class III, and the remainder were in functional class II. At baseline, the vitamin D group's mean 25(OH)D level was 19.1 ± 9.3 ng/ml and increased to 61.7 ± 20.3 ng/ml; in the placebo group, the mean baseline 25(OH)D level was 17.8 ± 9.0 ng/ml and decreased to 17.4 ± 9.8 ng/ml at 6 months (between-groups p < 0.001). There was no significant change from baseline to 6 months in peak oxygen uptake, 6-min walk distance, timed get up and go, or isokinetic muscle strength. Conclusions: Vitamin D3 did not improve physical performance in patients with HF despite a robust increase in serum 25(OH)D levels. Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation. (A Trial of Vitamin D Therapy in Patients With Heart Failure; NCT01125436).

Original languageEnglish (US)
Pages (from-to)84-90
Number of pages7
JournalJACC: Heart Failure
Volume1
Issue number1
DOIs
StatePublished - 2013

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Cholecalciferol
Randomized Controlled Trials
Heart Failure
Vitamin D
Muscle Strength
Placebos
Oxygen
Vitamin D Deficiency
African Americans
Knee
Guidelines
Calcium

Keywords

  • Heart failure
  • Trial
  • Vitamin D

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Boxer, R. S., Kenny, A. M., Schmotzer, B. J., Vest, M., Fiutem, J. J., & Pina, I. L. (2013). A randomized controlled trial of high-dose vitamin D3 in patients with heart failure. JACC: Heart Failure, 1(1), 84-90. https://doi.org/10.1016/j.jchf.2012.11.003

A randomized controlled trial of high-dose vitamin D3 in patients with heart failure. / Boxer, Rebecca S.; Kenny, Anne M.; Schmotzer, Brian J.; Vest, Marianne; Fiutem, Justin J.; Pina, Ileana L.

In: JACC: Heart Failure, Vol. 1, No. 1, 2013, p. 84-90.

Research output: Contribution to journalArticle

Boxer, RS, Kenny, AM, Schmotzer, BJ, Vest, M, Fiutem, JJ & Pina, IL 2013, 'A randomized controlled trial of high-dose vitamin D3 in patients with heart failure', JACC: Heart Failure, vol. 1, no. 1, pp. 84-90. https://doi.org/10.1016/j.jchf.2012.11.003
Boxer, Rebecca S. ; Kenny, Anne M. ; Schmotzer, Brian J. ; Vest, Marianne ; Fiutem, Justin J. ; Pina, Ileana L. / A randomized controlled trial of high-dose vitamin D3 in patients with heart failure. In: JACC: Heart Failure. 2013 ; Vol. 1, No. 1. pp. 84-90.
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N2 - Objectives: The aim of this study was to investigate the effect of vitamin D3 on physical performance in patients with heart failure (HF). Background: HF is associated with functional decline and frailty. Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF. Methods: Sixty-four patients participated in a 6-month parallel-design, double-blind randomized controlled trial to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly; all patients received daily calcium. Patients were included, regardless of ejection fraction, if they had 25 hydroxyvitamin D (25[OH]D) levels ≤37.5 ng/ml. The primary outcome was peak oxygen uptake, and secondary outcomes were 6-min walk distance, timed get up and go, and knee isokinetic muscle strength. Between-group comparisons were made using analysis-of-covariance models that adjusted for baseline measures. Results: Patients' mean age was 65.9 ± 10.4 years, 48% were women, 64% were African American, the mean ejection fraction was 37.6 ± 13.9%, 36% were in New York Heart Association functional class III, and the remainder were in functional class II. At baseline, the vitamin D group's mean 25(OH)D level was 19.1 ± 9.3 ng/ml and increased to 61.7 ± 20.3 ng/ml; in the placebo group, the mean baseline 25(OH)D level was 17.8 ± 9.0 ng/ml and decreased to 17.4 ± 9.8 ng/ml at 6 months (between-groups p < 0.001). There was no significant change from baseline to 6 months in peak oxygen uptake, 6-min walk distance, timed get up and go, or isokinetic muscle strength. Conclusions: Vitamin D3 did not improve physical performance in patients with HF despite a robust increase in serum 25(OH)D levels. Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation. (A Trial of Vitamin D Therapy in Patients With Heart Failure; NCT01125436).

AB - Objectives: The aim of this study was to investigate the effect of vitamin D3 on physical performance in patients with heart failure (HF). Background: HF is associated with functional decline and frailty. Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF. Methods: Sixty-four patients participated in a 6-month parallel-design, double-blind randomized controlled trial to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly; all patients received daily calcium. Patients were included, regardless of ejection fraction, if they had 25 hydroxyvitamin D (25[OH]D) levels ≤37.5 ng/ml. The primary outcome was peak oxygen uptake, and secondary outcomes were 6-min walk distance, timed get up and go, and knee isokinetic muscle strength. Between-group comparisons were made using analysis-of-covariance models that adjusted for baseline measures. Results: Patients' mean age was 65.9 ± 10.4 years, 48% were women, 64% were African American, the mean ejection fraction was 37.6 ± 13.9%, 36% were in New York Heart Association functional class III, and the remainder were in functional class II. At baseline, the vitamin D group's mean 25(OH)D level was 19.1 ± 9.3 ng/ml and increased to 61.7 ± 20.3 ng/ml; in the placebo group, the mean baseline 25(OH)D level was 17.8 ± 9.0 ng/ml and decreased to 17.4 ± 9.8 ng/ml at 6 months (between-groups p < 0.001). There was no significant change from baseline to 6 months in peak oxygen uptake, 6-min walk distance, timed get up and go, or isokinetic muscle strength. Conclusions: Vitamin D3 did not improve physical performance in patients with HF despite a robust increase in serum 25(OH)D levels. Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation. (A Trial of Vitamin D Therapy in Patients With Heart Failure; NCT01125436).

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