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      Effect of Cholecalciferol Supplementation on Inflammation and Cellular Alloimmunity in Hemodialysis Patients: Data from a Randomized Controlled Pilot Trial

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          Abstract

          Background

          Memory T-cells are mediators of transplant injury, and no therapy is known to prevent the development of cross-reactive memory alloimmunity. Activated vitamin D is immunomodulatory, and vitamin D deficiency, common in hemodialysis patients awaiting transplantation, is associated with a heightened alloimmune response. Thus, we tested the hypothesis that vitamin D 3 supplementation would prevent alloreactive T-cell memory formation in vitamin D-deficient hemodialysis patients.

          Methods and Findings

          We performed a 12-month single-center pilot randomized, controlled trial of 50,000 IU/week of cholecalciferol (D 3) versus no supplementation in 96 hemodialysis patients with serum 25(OH)D<25 ng/mL, measuring effects on serum 25(OH)D and phenotypic and functional properties of T-cells. Participants were randomized 2∶1 to active treatment versus control. D 3 supplementation increased serum 25(OH)D at 6 weeks (13.5 [11.2] ng/mL to 42.5 [18.5] ng/mL, p<0.001) and for the duration of the study. No episodes of sustained hypercalcemia occurred in either group. Results of IFNγ ELISPOT-based panel of reactive T-cell assays (PRT), quantifying alloreactive memory, demonstrated greater increases in the controls over 1 year compared to the treatment group (delta PRT in treatment 104.8+/−330.8 vs 252.9+/−431.3 in control), but these changes in PRT between groups did not reach statistical significance (p = 0.25).

          Conclusions

          D 3 supplements are safe, effective at treating vitamin D deficiency, and may prevent time-dependent increases in T-cell alloimmunity in hemodialysis patients, but their effects on alloimmunity need to be confirmed in larger studies. These findings support the routine supplementation of vitamin D-deficient transplant candidates on hemodialysis and highlight the need for large-scale prospective studies of vitamin D supplementation in transplant candidates and recipients.

          Trial Registration

          Clinicaltrials.gov NCT01175798

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          Most cited references19

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          The CD14+ CD16+ blood monocytes: their role in infection and inflammation.

          Loems Ziegler-Heitbrock (2007)
          Blood monocyte subpopulations have been defined in man initially, and the two major types of monocytes are the CD14++ CD16- and the CD14+ CD16+ monocytes. These cells have been shown to exhibit distinct phenotype and function, and the CD14+ CD16+ were labeled proinflammatory based on higher expression of proinflammatory cytokines and higher potency in antigen presentation. The current review describes these properties, including the relationship to dendritic cells, and summarizes the host of publications about CD14+ CD16+ monocytes in inflammation and infectious disease in man, all of which suggest a crucial role of these cells in the disease processes. The review also covers the more recent description of homologues of these cells in other model species, which is expected to better define the role of monocyte subsets in disease.
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            Random allocation software for parallel group randomized trials

            Mahmoud Saghaei, Mahmood Saghaei (2004)
            Background Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none of them have all of these capabilities integrated into one package. The main objective of the Random Allocation Software project was to enhance the user's control over different aspects of randomization in parallel group trials, including output type and format, structure and ordering of generated unique identifiers and enabling users to specify group names for more than two groups. Results The program has different settings for: simple and blocked randomizations; length, format and ordering of generated unique identifiers; type and format of program output; and saving sessions for future use. A formatted random list generated by this program can be used directly (without further formatting) by the coordinator of the research team to prepare and encode different drugs or instruments necessary for the parallel group trial. Conclusions Random Allocation Software enables users to control different attributes of the random allocation sequence and produce qualified lists for parallel group trials.
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              Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

              P H Rayner, Takashi Akiba, Jock W. Young … (2003)
              Mortality rates among hemodialysis patients vary greatly across regions. Representative databases containing extensive profiles of patient characteristics and outcomes are lacking. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States (US) that captures extensive data relating to patient characteristics, prescriptions, laboratory values, practice patterns, and outcomes. This report describes the case-mix features and mortality among 16,720 patients followed up to 5 yr. The crude 1-yr mortality rates were 6.6% in Japan, 15.6% in Europe, and 21.7% in the US. After adjusting for age, gender, race, and 25 comorbid conditions, the relative risk (RR) of mortality was 2.84 (P < 0.0001) for Europe compared with Japan (reference group) and was 3.78 (P < 0.0001) for the US compared with Japan. The adjusted RR of mortality for the US versus Europe was 1.33 (P < 0.0001). For most comorbid diseases, prevalence was highest in the US, where the mean age (60.5 +/- 15.5 yr) was also highest. Older age and comorbidities were associated with increased risk of death (except for hypertension, which carried a multivariate RR of mortality of 0.74 [P < 0.0001]). Variability in demographic and comorbid conditions (as identified by dialysis facilities) explains only part of the differences in mortality between dialysis centers, both for comparisons made across continents and within the US. Adjustments for the observed variability will allow study of association between practice patterns and outcomes.
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                Author and article information

                Contributors
                Kathrin Eller: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS ONE
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Electronic): 1932-6203
                Publication date Collection: 2014
                Publication date (Electronic): 8 October 2014
                Volume: 9
                Issue: 10
                Electronic Location Identifier: e109998
                Affiliations
                [1 ]Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [2 ]Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [3 ]Recanati Miller Transplantation Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [4 ]Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [5 ]Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [6 ]Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                [7 ]Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America
                Medical University of Graz, Austria
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: AM PSH. Performed the experiments: LL ML MK KO AB. Analyzed the data: LL AM. Contributed reagents/materials/analysis tools: AG-S RA. Contributed to the writing of the manuscript: LL AM ADB JU PSH. Study subject recruitment: JT SL BR VL.

                ¶ These authors are co-senior authors on this work.

                Article
                Publisher ID: PONE-D-14-25846
                DOI: 10.1371/journal.pone.0109998
                PMC ID: 4190314
                PubMed ID: 25296334
                SO-VID: 99303ab4-b003-476e-a091-e42a3410f8b5
                Copyright statement: Copyright @ 2014
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 13 June 2014
                Date accepted : 2 September 2014
                Page count
                Pages: 9
                Funding
                This work was supported by grants from the Doris Duke Charitable Foundation (LL), National Kidney Foundation (PSH), American Heart Association (AM), and National Institute of Health: DK090317, DA0301095 (ADB), U01AI063594 (PSH), U19AI089987 (AG-S, RA), and UL1TR000067 from the National Center for Advancing Translational Sciences. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Subject: Research Article
                Subject: Biology and life sciences
                Subject: Immunology
                Subject: Immune Response
                Subject: Lymphocyte Activation
                Subject: Immunity
                Subject: Cell-Mediated Immunity
                Subject: Immune Activation
                Subject: Immune Suppression
                Subject: Immunomodulation
                Subject: Nutrition
                Subject: Nutritional deficiencies
                Subject: Vitamin D deficiency
                Subject: Medicine and Health Sciences
                Subject: Nephrology
                Subject: Medical Dialysis
                Custom metadata
                Data Availability The authors confirm that all data underlying the findings are fully available without restriction. Data are available from the authors of the study ( anita.mehrotra@ 123456mssm.edu ) upon approval of the request by the Icahn School of Medicine at Mount Sinai Institutional Review Board (ISMMS IRB).

                ScienceOpen disciplines: Uncategorized
                Data availability:
                ScienceOpen disciplines: Uncategorized

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