Dataset Information

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

ABSTRACT:

Objective

To investigate the effect of Vitamin D3 on physical performance in patients with 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 RCT to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly; all received daily calcium. Patients were included regardless of EF and 25OHD ≤ 37.5 ng/ml. The primary outcome was peak VO2, and secondary outcomes were the 6MW, TGUG and knee isokinetic muscle strength. Between group comparisons were made using ANCOVA models that adjust for baseline measures.

Results

Patients were age 65.9 ± 10.4 years old, 48% women, 64% African American, EF 37.6±13.9, 36% NYHA III, the remainder NYHA II. At baseline the vitamin D group 25OHD was 19.1 ± 9.3 ng/ml and increased to 61.7 ± 20.3 ng/ml; in the placebo group baseline 25OHD 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 VO2, 6MW, TGUG or isokinetic muscle strength.

Conclusions

Vitamin D3 did not improve physical performance for patients with HF despite a robust increase in serum 25OHD. Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation.

SUBMITTER: Boxer RS

PROVIDER: S-EPMC3845907 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Boxer Rebecca S RS Kenny Anne M AM Schmotzer Brian J BJ Vest Marianne M Fiutem Justin J JJ Piña Ileana L IL

JACC. Heart failure 20130201 1

<h4>Objective</h4>To investigate the effect of Vitamin D3 on physical performance in patients with HF.<h4>Background</h4>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.<h4>Methods</h4>Sixty-four patients participated in a 6-month parallel design double blind RCT to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly ...[more]

PMID: 24614995

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Project description:IntroductionVitamin D deficiency is encountered frequently in critically ill patients and might be harmful. Current nutrition guidelines recommend very low vitamin D doses. The objective of this trial was to evaluate the safety and efficacy of a single oral high-dose vitamin D3 supplementation in an intensive care setting over a one-week observation period.MethodsThis was a randomized, double-blind, placebo-controlled pilot study in a medical ICU at a tertiary care university center in Graz, Austria. Twenty-five patients (mean age 62 ± 16 yrs) with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 20 ng/ml] and an expected stay in the ICU >48 hours were included and randomly received either 540,000 IU (corresponding to 13.5 mg) of cholecalciferol (VITD) dissolved in 45 ml herbal oil or matched placebo (PBO) orally or via feeding tube.ResultsThe mean serum 25(OH)D increase in the intervention group was 25 ng/ml (range 1-47 ng/ml). The highest 25(OH)D level reached was 64 ng/ml, while two patients showed a small (7 ng/ml) or no response (1 ng/ml). Hypercalcemia or hypercalciuria did not occur in any patient. From day 0 to day 7, total serum calcium levels increased by 0.10 (PBO) and 0.15 mmol/L (VITD; P < 0.05 for both), while ionized calcium levels increased by 0.11 (PBO) and 0.05 mmol/L (VITD; P < 0.05 for both). Parathyroid hormone levels decreased by 19 and 28 pg/ml (PBO and VITD, ns) over the seven days, while 1,25(OH)D showed a transient significant increase in the VITD group only.ConclusionsThis pilot study shows that a single oral ultra-high dose of cholecalciferol corrects vitamin D deficiency within 2 days in most patients without causing adverse effects like hypercalcemia or hypercalciuria. Further research is needed to confirm our results and establish whether vitamin D supplementation can affect the clinical outcome of vitamin D deficient critically ill patients. EUDRACT NUMBER: 2009-012080-34 GERMAN CLINICAL TRIALS REGISTER (DRKS): DRKS00000750.

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Dataset Information

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

Objective

Background

Methods

Results

Conclusions

Publications

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

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