Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial.

BACKGROUND: Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation. METHODS: This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1ß, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1ß, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV1, pulmonary exacerbations, antibiotic use, nutritional status and quality of life). RESULTS: Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups. CONCLUSION: In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).

Mineral metabolism factors predict accelerated progression of common carotid intima-media thickness in chronic kidney disease: the NEFRONA study.

BACKGROUND: The leading cause of premature death in chronic kidney disease (CKD) is cardiovascular disease (CVD), but risk assessment in renal patients is challenging. The aim of the study was to analyse the factors that predict accelerated progression of common carotid intima-media thickness (CCIMT) in a CKD cohort after 2 years of follow-up (2010-12). METHODS: The study included 1152 patients from the NEFRONA cohort with CKD stages 3-5D and without a clinical history of CVD. CCIMT was measured at the far wall on both common carotids. CCIMT progression was defined as the change between CCIMT at baseline and at 24 months for each side, averaged and normalized as change per year. Accelerated progressors were defined as those with a CCIMT change ≥75th percentile. RESULTS: The median CCIMT progression rate was 0.0125 mm/year, without significant differences between CKD stages. The cut-off value for defining accelerated progression was 0.0425 mm/year. After adjustment, age was a common factor among all CKD stages. Traditional cardiovascular risk factors, such as diabetes and systolic blood pressure, were predictors of progression in CKD stages 4-5, whereas high-density lipoprotein and low-density lipoprotein cholesterol predicted progression in women in stage 3. Mineral metabolism factors predicting accelerated progression were serum phosphorus in stages 3 and 5D; low 25-hydroxyvitamin D and parathyroid hormone levels >110 pg/mL in stages 4-5 and intact parathyroid hormone levels out of the recommended range in stage 5D. CONCLUSIONS: Mineral metabolism parameters might predict accelerated CCIMT progression from early CKD stages.

The effect of replacing aluminium hydroxide with calcium acetate/magnesium carbonate on serum phosphorus control in haemodialysis patients.

INTRODUCTION: Calcium acetate/magnesium carbonate (MgCO3) is a phosphorus binder with advantages in terms of cost, safety and tolerance and it has a similar efficacy to other drugs. The objective of the study is to assess the effects of replacing aluminium hydroxide [Al(OH3)] with MgCO3 on phosphorus and calcium metabolism in a cohort of haemodialysis patients. MATERIALS AND METHODS: We included 21 patients with phosphorus <5mg/dl, with Al(OH3) as the only binder. The conversion to MgCO3 was carried out without changing the number of pills. We recorded clinical-demographic characteristics, treatment for secondary hyperparathyroidism and laboratory parameters before conversion and every month for four months. RESULTS: Phosphataemia decreased from 4.52 ± 0.99 to 4.02 ± 1.07 mg/dl (p=.027), and there was a decrease in the calcium-phosphorus product from 40.20 ± 10.44 to 35.16 ± 11.06 mg2/dl2 (p=.037). We did not observe significant changes in levels of calcium, parathyroid hormone or 25-OH-vitamin D3. The daily number of pills prescribed was reduced from 3.33 ± 2.29 to 2.15 ± 2.21 (p=.020). Concomitant treatments were not altered. We observed an initial significant increase in magnesaemia from 2.21 ± 0.24 to 2.43 ± 0.39 mg/dl (p=.001), which subsequently remained stable. We found a decrease in serum aluminium from 14.91 ± 8.55 to 8.47 ± 3.98 µg/l (p=.004), with levels within the recommended range in all patients. CONCLUSIONS: MgCO3 allowed good control of serum phosphorus in haemodialysis patients who were previously well controlled with Al(OH)3, using fewer daily pills. There was a slight increase in serum magnesium, without short-term clinical significance. We do not know the effects of this increase in the longer term.