Plain language summary
A vitamin D deficiency in patients with heart failure (HF) seems to be associated with less favourable outcomes. Vitamin D status may influence several of the hormones that are important to keep the heart working normally. The objective of this study was to determine if vitamin D3 supplementation would replete vitamin D stores, improve the hormones b-type natriuretic peptide (BNP) and parathyroid hormone (PTH), improve heart and lung function, reduce inflammation, and improve quality of life (QOL) in HF patients. This was a 6 month randomised controlled trial, using a dose of 10,000 IU of vitamin D3 daily or a placebo, in 40 vitamin D deficient or insufficient (≤ 32 ng/ml) patients with stable HF. All variables were measured at baseline and 6 months. The change in BNP from baseline was +30pg/ml in the vitamin D group vs. +400pg/ml in the placebo group (p = 0.003). Vitamin D blood levels rose by 49ng/ml in the treatment group vs 4ng/ml in the placebo group (p < 0.001). Other measures of heart function were unchanged. The inflammatory marker high sensitivity C-reactive protein (hsCRP) remained unchanged for women, but modestly improved for men in the group given vitamin D. QOL scores significantly improved in the vitamin D group compared to placebo. The authors concluded that repletion of vitamin D may improve quality of life in heart failure patients and may help to normalise b-type natriuretic peptide, parathyroid hormone and high sensitivity C-reactive protein.
Abstract
BACKGROUND Vitamin D status may influence heart failure (HF) patient outcomes by affecting b-type natriuretic peptide (BNP), parathyroid hormone (PTH), and enhancing cardiac contractility. Vitamin D deficiency is associated with morbidity and mortality in HF patients. The objective of this study was to determine if vitamin D3 at a comparatively high dose would replete 25-hydroxyvitamin D (25(OH)D) stores, improve BNP, PTH, cardiopulmonary function, reduce inflammatory markers, and improve quality of life (QOL) in HF patients. METHODS This was a 6 month, parallel group, double-blind, placebo-controlled, single clinic center, randomized trial of supplemental vitamin D3 using a dose of 10,000 IU daily or placebo in 40 vitamin D deficient or insufficient (25(OH)D level ≤ 32 ng/ml) patients with stable New York Heart Association Class II-III HF in a specialty cardiology clinic. All variables were measured at baseline and 6 months. Values between the two treatment groups were assessed using Student's t-test or Mann-Whitney Test. Univariate analysis of covariance was conducted to adjust for variance in baseline 25(OH)D. RESULTS All results were adjusted for baseline 25(OH)D. The change in BNP from baseline was ∆ +30 ± 950 pg/ml for treatment vs. placebo ∆ +400 ± 1900 pg/ml, p = 0.003. 25(OH)D serum levels rose by 49 ± 32 ng/ml in the treatment group vs 4 ± 10 ng/ml in the placebo group, p < 0.001. PTH and exercise chronotropic response index improved in the treatment group vs placebo group, respectively, but both were attenuated by adjustment ((∆-20 ± 20 pg/ml vs ∆ + 7 ± 53 pg/ml respectively (p = 0.01, adjusted p = 0.07)) and (∆ + 0.13 ± 0.26 vs. ∆-0.03 ± 02.9 respectively, p < 0.01, adjusted p = 0.17)). Other measured cardiopulmonary parameters remained unchanged. High sensitivity C-reactive protein (hsCRP) remained unchanged for women, but improved for men (∆-2 ± 4 treatment versus ∆2 ± 5 mg/L placebo, p = 0.05). QOL scores, including composite overall and clinical summary scores significantly improved in treatment compared to placebo (∆ + 10 ± 15 versus -6 ± 15, p < 0.01 and ∆ + 8 ± 14 versus -8 ± 18, p = 0.01, respectively). CONCLUSIONS Repletion of 25(OH)D may improve QOL in HF patients and may help to normalize BNP, PTH, and hsCRP. TRIAL REGISTRATION Clinicaltrials.gov, Trial Registration Number: NCT01636570 , First registered 3 July 2012.
Methodological quality
Jadad score
:
5
Allocation concealment
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Yes
