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Vitamin D3 repletion versus placebo as adjunctive treatment of heart failure patient quality of life and hormonal indices: a randomized, double-blind, placebo-controlled trial.
Moretti, HD, Colucci, VJ, Berry, BD
BMC cardiovascular disorders. 2017;17(1):274
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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.
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Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet.
Shai, I, Schwarzfuchs, D, Henkin, Y, Shahar, DR, Witkow, S, Greenberg, I, Golan, R, Fraser, D, Bolotin, A, Vardi, H, et al
The New England journal of medicine. 2008;359(3):229-41
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Most trials comparing the effectiveness of weight-loss regimes are carried out over short durations. This trial explored the effectiveness of three dietary protocols (low carbohydrate, Mediterranean diet and low fat) on weight loss over 2 years. The study randomly allocated 322 moderately obese subjects to one of the three dietary regimes. The mean weight loss for the 272 people completing the study after 2 years was significantly different between the groups; 3.3kg for the low fat group, 4.6kg for the Mediterranean diet group and 5.5kg for the low carbohydrate group. Diabetic subjects in the Mediterranean group achieved more favourable fasting blood sugar and insulin levels compared to the low fat group. The low carbohydrate group achieved the most favourable outcomes in terms of their lipid profiles compared to the other groups. The authors concluded that the Mediterranean diet and low carbohydrate diets may be effective alternatives to low fat regimes; they achieved weight-loss and also some metabolic benefits.
Abstract
BACKGROUND Trials comparing the effectiveness and safety of weight-loss diets are frequently limited by short follow-up times and high dropout rates. METHODS In this 2-year trial, we randomly assigned 322 moderately obese subjects (mean age, 52 years; mean body-mass index [the weight in kilograms divided by the square of the height in meters], 31; male sex, 86%) to one of three diets: low-fat, restricted-calorie; Mediterranean, restricted-calorie; or low-carbohydrate, non-restricted-calorie. RESULTS The rate of adherence to a study diet was 95.4% at 1 year and 84.6% at 2 years. The Mediterranean-diet group consumed the largest amounts of dietary fiber and had the highest ratio of monounsaturated to saturated fat (P<0.05 for all comparisons among treatment groups). The low-carbohydrate group consumed the smallest amount of carbohydrates and the largest amounts of fat, protein, and cholesterol and had the highest percentage of participants with detectable urinary ketones (P<0.05 for all comparisons among treatment groups). The mean weight loss was 2.9 kg for the low-fat group, 4.4 kg for the Mediterranean-diet group, and 4.7 kg for the low-carbohydrate group (P<0.001 for the interaction between diet group and time); among the 272 participants who completed the intervention, the mean weight losses were 3.3 kg, 4.6 kg, and 5.5 kg, respectively. The relative reduction in the ratio of total cholesterol to high-density lipoprotein cholesterol was 20% in the low-carbohydrate group and 12% in the low-fat group (P=0.01). Among the 36 subjects with diabetes, changes in fasting plasma glucose and insulin levels were more favorable among those assigned to the Mediterranean diet than among those assigned to the low-fat diet (P<0.001 for the interaction among diabetes and Mediterranean diet and time with respect to fasting glucose levels). CONCLUSIONS Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions. (ClinicalTrials.gov number, NCT00160108.)