Acid wolf gif

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The center horizontal line in each box indicates the median; top and bottom box borders indicate the first and third quartiles, respectively. Whiskers depict the most extreme observation within 1. Urine ACR plots are shown on a log scale.

s shown are participants contributing data at each time point. Body mass index is calculated as weight in kilograms divided by height in meters squared. Estimates are differences in change in eGFR from baseline to year 5 comparing active treatment with placebo, adjusted for age, sex, and baseline urine ACR. Question In Acid wolf gif with type 2 diabetes, do vitamin D or omega-3 fatty acid supplements help prevent development or progression of kidney disease? Meaning These findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in adults with type 2 diabetes.

Importance Chronic kidney disease CKD is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes. Objective To test whether supplementation with vitamin D 3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes. Follow-up was completed in December Main Outcomes and Measures The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C eGFR Acid wolf gif baseline to year 5.

Among participants randomized mean age, Baseline mean eGFR was There was no ificant interaction between the 2 interventions. Conclusions and Relevance Among adults with type 2 diabetes, supplementation with vitamin D 3 or omega-3 fatty acids, compared with placebo, resulted in no ificant difference in change in eGFR at 5 years.

The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes. Trial Registration ClinicalTrials. Vitamin D and omega-3 fatty acid supplements are interventions that may have the potential to prevent the development and progression of CKD in type 2 diabetes. However, clinical trials evaluating the kidney effects of vitamin D and omega-3 fatty acid supplements have been of short duration, evaluated only urine albumin excretion as an outcome, or examined kidney outcomes as secondary post hoc analyses.

Participants were enrolled from 50 states. Baseline blood samples were collected by the parent trial for approximately two-thirds of participants, with follow-up blood samples and urine samples collected only among a subset of generally healthy participants Acid wolf gif in Boston. For this study, we enrolled a subset of parent trial participants with type 2 diabetes at baseline to ascertain CKD outcomes trial protocol available in Supplement 1.

The study was approved by the Partners Human Research Committee. Participants provided written informed consent and received a stipend. The parent trial enrolled men aged 50 years or older and women aged 55 years or older without clinically apparent cardiovascular disease or cancer.

We excluded those who reported a diagnosis of diabetes only during pregnancy, a diagnosis of diabetes prior to age 30 years treated with insulin for more than 20 years, or a known cause of CKD other than diabetes. Omega-3 fatty acids fish oil, 1-g capsules containing mg of eicosapentaenoic acid [EPA] plus mg of docosahexaenoic acid [DHA] and matching inert placebo were provided by ProNova.

Randomization occurred from Novemberthrough March Asments were computer generated in blocks of 8 stratified by age, sex, and race. Treatment asments were concealed to both participants and investigators. The original primary outcome was change in albuminuria but was modified when the study duration was extended to 5 years inallowing sufficient time to assess meaningful differences in eGFR. Kidney failure was ascertained yearly by questionnaire.

Urine was collected from first morning voids, and albumin and creatinine were measured on a Beckman DXC chemistry analyzer.

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Blood and urine samples were collected by mail prior to randomization baseline2 years after randomization, and 5 years after randomization. Creatinine are traceable to isotope dilution mass spectrometry. A shift in cystatin C values was identified with change in calibrator lot.

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Baseline demographics, duration of diabetes, comorbidities, smoking and alcohol use, weight, and height were ascertained by self-report. Race and ethnicity were self-reported by participants using fixed to ensure that a diverse population was enrolled and to facilitate exploring racial and ethnic heterogeneity in treatment effects.

Body mass index was calculated as weight divided by height squared. Medication use at baseline and follow-up was ascertained using a detailed questionnaire that listed all glucose- and blood pressure—lowering medications available at the time of administration, updated throughout the study. Adherence to study medications was assessed by self-report, with a subset of highly adherent participants defined as reporting use of study medications at least two-thirds of the time.

At baseline and year 2, serum 25 OH D concentrations and the plasma omega-3 index EPA plus DHA as a percentage of total fatty acids were measured by liquid chromatography—tandem mass spectrometry. C-reactive protein was measured on a Beckman DXC chemistry analyzer. We Acid wolf gif linear mixed models to summarize changes in eGFR and urine ACR over time and to test whether these changes differed by treatment asment.

Random intercepts were included in the linear mixed models to for the correlation within participant. Terms for linear age, sex, and their interactions with time were also included. The P value for interaction of treatment with time year 5 was used to test treatment effects.

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Because of the potential for type I error due to multiple comparisons, findings for analyses of secondary end points should be interpreted as exploratory. For primary analyses, all participants were analyzed according to their randomized treatment group, regardless of adherence or follow-up full analytic population. For the vitamin D intervention, prespecified subgroup analyses were defined based on race and ethnicity and baseline 25 OH D concentrations, urine ACR, and eGFR 6 ; body mass index Acid wolf gif added when the parent trial reported interaction by body mass index with regard to incident cancer.

We examined secondary categorical outcomes using Cox proportional hazards models and tested the proportional hazards assumption using Schoenfeld residuals. All analyses were conducted using the R version 3. At baseline, participants enrolled in this study had a mean age of Mean baseline eGFR was Two years after randomization, mean serum 25 OH D concentrations were Two years after randomization, mean omega-3 indexes were 3.

Regardless of treatment asment, proportions of participants using biguanides, sulfonylureas, insulin, and angiotensin-converting enzyme inhibitors remained relatively stable over the course of the study eTables 2 and 3 in Supplement 2.

Mean eGFR was At year 5, there was no ificant difference in change in eGFR according to treatment 0. Similar were observed when analyses were restricted to participants who provided serum samples at baseline and year 5 or to participants who reported consistent high adherence to study medications eTables 4 and 5 in Supplement 2.

No ificant subgroup heterogeneity was observed for the effect of either vitamin D or omega-3 fatty acids on change in eGFR Figure 3 and Figure 4. Neither change in serum 25 OH D nor change in omega-3 index from baseline to year 2 ificantly correlated with change in eGFR from baseline to year 5 eFigure 1 in Supplement 2.

Of 3 prespecified secondary outcomes, none differed ificantly by treatment asment for either intervention. The geometric mean urine ACR was 5. Urine ACR increased approximately 3-fold from baseline to year 5, but there was no ificant difference in Acid wolf gif in urine ACR according to asment to vitamin D or placebo or to omega-3 fatty acids or placebo Table 3 and eTable 6 in Supplement 2.

Similar were observed in relevant subgroups, when analyses were restricted to participants who provided urine samples at baseline and year 5, when analyses were restricted to those reporting consistent adherence to study medications, and when participants who reported symptoms of possible urinary tract infection at the time of urine collection were excluded eFigures 2 and Acid wolf gif and eTables 7, 8, and 9 in Supplement 2.

There were no statistically ificant violations of the proportional hazards assumption for any secondary outcome. Adverse events were similar comparing both vitamin D and omega-3 fatty acid supplementation with respective placebos eTable 11 in Supplement 2. For example, kidney stones occurred among 58 participants 32 receiving vitamin D 3 and 26 receiving placebo and gastrointestinal bleeding occurred among 45 participants 28 receiving omega-3 fatty acids and 17 receiving placebo.

Quiz Ref ID Among adults with type 2 diabetes in this randomized clinical trial, neither vitamin D nor omega-3 fatty acid supplementation ificantly slowed eGFR decline over 5 years. were consistent in sensitivity analyses restricted to participants with complete data or to participants who were adherent to study interventions, and secondary outcomes of large changes in eGFR and change in urine albumin excretion also showed no statistically ificant differences between groups.

Altogether, these suggest that neither vitamin D nor omega-3 fatty acids have appreciable kidney benefits among the broad population of patients with diagnosed type 2 diabetes. Quiz Ref ID This study assessed change in eGFR over 5 years as the primary outcome because this is a clinically relevant outcome with which treatment effects could be assessed with high power. In the setting of type 2 diabetes, 5 years is sufficient time for substantial eGFR decline to occur with standard treatments. Mean eGFR in the study population decreased by Changes in medications over the course of the study could also affect change in eGFR, but medication changes were small in this study and similar across randomized groups.

The study was powered to detect even modest differences in change in eGFR, as little as 2. There were insufficient s of events to effectively evaluate treatment effects on this outcome, which is conceptually similar to the primary outcome but is considered a valid surrogate outcome for ESKD.

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Urine albumin excretion, a marker of kidney damage that Acid wolf gif complementary to eGFR, was low in the study population but did increase approximately 3-fold over the course of the study. However, mean urine albumin excretion was also not ificantly affected by vitamin D or omega-3 fatty acids. Null for secondary outcomes support the overall lack of effect for the primary outcome and suggest that neither vitamin D nor omega-3 fatty acids have kidney effects in this study population.

In a meta-analysis of short-term clinical trials, treatment with 1,dihydroxyvitamin D 3 or a 1,diydroxyvitamin D 3 analogue reduced urine albumin excretion, compared with placebo. Supplemental forms of vitamin D, such as vitamin D 3may be more appropriate for widespread use for prevention. Prior clinical trials of vitamin D 3 assessing kidney outcomes have been small range, participants and of short duration. A meta-analysis of 17 small clinical trials a total of participants with varied causes of CKD, including diabetes suggested that omega-3 fatty acid supplementation reduced albuminuria but did not have ificant effects on eGFR.

Quiz Ref ID The of this study apply to relatively healthy adults with type 2 diabetes. There were few participants with these characteristics, and the trial was not powered to assess these specific participants. Strengths of this study include the rigorous randomized de, the relatively large sample size and long duration of follow-up for the interventions studied, good adherence to study medications to enhance internal validity, and consistent in sensitivity analyses and evaluation of secondary outcomes.

This study has several limitations. First, there were modest s of eGFR and urine ACR measurements collected per participant, limiting evaluation of slopes and time-to-event analyses. Second, there were insufficient s of events for widely accepted surrogate kidney end points, which were evaluated as secondary outcomes. Third, power was limited to assess effects among subgroups who may derive more benefit from the study interventions Acid wolf gif the overall type 2 diabetes population.

The primary analytic approach ed for missing data to minimize bias, and a complete case approach yielded similar. Among adults with type 2 diabetes, supplementation with vitamin D 3 or omega-3 fatty acids, compared with placebo, resulted in no ificant difference in change in eGFR at 5 years.

Corresponding Author: Ian H. Published Online: November 8, Correction: This article was corrected on June 3,for additional conflict of interest disclosures. Author Contributions: Dr de Boer had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy Acid wolf gif the data analysis.

Conflict of Interest Disclosures: Dr de Boer reported receipt of consulting fees from Boehringer Ingelheim and Ironwood and equipment and supplies for research from Medtronic and Abbott. Dr Hoofnagle reported that his laboratory received payment for services from DiaSorin Inc.

Dr Thadhani reported holding a patent pending on measurement of bioavailable vitamin D and receiving payment for services or consulting for Fresenius Medical Care North America, Alnylam, Agios Pharmaceuticals, Bayer, Genzyme, and Pfizer and a grant for research from Fisher Scientific.

Dr Buring reported that her spouse is a member of the scientific advisory board of Pharmavite, which provided the vitamin D pills and packaging for the trial. Dr Sesso reported receipt of grants from Pure Encapsulations. Dr Manson reported receipt of grants from the National Institutes of Health. No other disclosures were reported. Additional support was provided by an unrestricted fund from the Northwest Kidney Centers. Wenger, MD chair; Emory University ; these members received a stipend for their service. Costello, PhD; Cindy D. Data Sharing Statement: See Supplement 3.

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Acid wolf gif

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