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SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING

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SCHIZOPHRENIA BULLETIN 2019年第Suppl 2期45卷 S295-S296页

作者： Garcia-Portilla, M. P. Llorca, P. M. Maina, G. Bozikas, V. P. Devrimci-Ozguven, H. Kim, S. W. Bergmans, P. Usankova, I. Cherubin, P. Najarian, Dean Pungor, K. Univ Oviedo CIBERSAM G05 Oviedo Spain CHR Univ Clermont Ferrand Pole Psychiat Clermont Ferrand France Univ Torino AOU San Luigi Gonzaga SCDU Psichiat Turin Italy Aristotle Univ Thessaloniki Sch Med Thessaloniki Greece Ankara Univ Sch Med Ankara Turkey Chonnam Natl Univ Med Sch Gwangju South Korea Janssen Cilag Biostat & Programming Breda Netherlands Johnson & Johnson EMEA Med Affairs Org Moscow Russia Janssen Cilag EMEA Med Affairs Issy Les Moulineaux France Janssen Sci Affairs Titusville NJ USA Janssen Cilag EMEA Med Affairs Dusseldorf Germany

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In Vivo Analysis of Biceps Tendon Characteristics in Subpectoral Tenodesis

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ARTHROSCOPY-THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY 2017年第8期33卷 1495-1502页

作者： Mirzayan, Raffy Takara, Tadashi Batech, Michael McCrum, Christopher L. Kaiser Permanente Dept Orthopaed Surg 1011 Baldwin Pk Blvd Baldwin Pk CA 91706 USA Ventura Cty Med Ctr Dept Orthoped Surg Ventura CA USA Kaiser Permanente Southern Calif Res & Evaluat Dept Dept Biostat Programming & Res Database Serv Pasadena CA USA Univ Pittsburgh Ctr Sports Med Dept Orthopaed Surg Pittsburgh PA USA

Purpose: To report the in vivo characteristics of the long head of the biceps tendon (LHBT);to evaluate the relation of age, gender, height, weight, and body mass index to the length and sutured and tubularized diameter of the LHBT;and to determine the smallest possible tunnel diameter for a subpectoral biceps tenodesis (SPBT) that can accommodate most patients. Methods: The study included 66 patients (33 men and 33 women) with an average age of 54 years (range, 29-73 years) undergoing SPBT. After tenotomy, the length from the biceps musculotendinous junction to the released end was measured. The tendon was transected 3 cm proximal to the musculotendinous junction and sutured, and the diameter was measured. The depth of the reamed tunnel was recorded. Results: The average tendon length was 84.0 mm, measuring 91.9 mm in men and 76.2 mm in women (P < .001), and the average tendon diameter was 4.4 mm, varying slightly between men (4.5 mm) and women (4.3 mm) (P < .001). Mean bone tunnel depth was 17.5 mm, with 19 mm in men and 16.1 mm in women (P < .001). Patient height showed a significant relation to both tendon length and tendon diameter. Weight was not correlated with tendon diameter but did show a significant relation to tendon length. Conclusions: We have characterized the in vivo length and diameter of the LHBT at the time of an SPBT. Our findings have shown that there was a statistically significant gender difference in tendon length and diameter, but the diameter of the sutured tendon, which was placed into the tunnel, averaged 4.4 mm and ranged from 3.5 to 5 mm for all ages, both genders, all heights, and all weights. This finding is clinically relevant in that a small tunnel measuring 5.5 mm or less is sufficient to perform an SPBT.

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On Quantitative Methods for Clinical Safety Monitoring in Drug Development

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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2018年第2期10卷 85-97页

作者： Wang, William Whalen, Ed Munsaka, Melvin Li, Judy Fries, Michael Kracht, Karolyn Sanchez-Kam, Matilde Singh, Krishan Zhou, Kefei Merck Inc Clin Safety Stat Merck Res Labs N Wales PA USA Pfizer Inc Global Biometr 235 East 42nd St New York NY 10017 USA AbbVie Inc Stat Sci Safety Stat N Chicago IL USA Takeda Pharmaceut Deerfield IL USA Regeneron Pharmaceut Inc Clin Dev & Regulatory Affairs Tarrytown NY USA US FDA Washington DC 20204 USA CSL Behring Global Stat King Of Prussia PA USA AbbVie Inc Safety Decis Analyt N Chicago IL USA SanchezKam LLC Alexandria VA USA Glaxo Smith Kline Plc Stat Programming & Data Sci Collegeville PA USA Theravance Biopharma US Inc Biostat San Francisco CA USA Amgen Inc San Francisco CA USA

Safety monitoring and reporting has achieved a greater level of attention in the past 15years. Statisticians play an important role in learning about a drug's safety profile. An ASA safety monitoring working group was established with a goal to empower the biostatistics community to play a proactive role and better enable quantification in safety monitoring. As part of its effort, this article presents a systematic review and unique perspective on the existing methodology developments, which include Bayesian and frequentist, blinded versus unblinded safety monitoring, individual versus aggregate data meta-analyses, pre-, and post-marketing methods, static versus dynamic safety reviews, and methods of visualization. These perspectives may serve as a background for future statistical work, both in methodology development and its application.

关键词： Aggregate analyses IND safety reporting Safety monitoring

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The association between birth order and childhood leukemia may be modified by paternal age and birth weight. Pooled results from the International Childhood Cancer Cohort Consortium (I4C)

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INTERNATIONAL JOURNAL OF CANCER 2019年第1期144卷 26-33页

作者： Paltiel, Ora Lemeshow, Stanley Phillips, Gary S. Tikellis, Gabriella Linet, Martha S. Ponsonby, Anne-Louise Magnus, Per Haberg, Siri E. Olsen, Sjurdur F. Granstroem, Charlotta Klebanoff, Mark Golding, Jean Herceg, Zdenko Ghantous, Akram Hirst, Jane Elizabeth Borkhardt, Arndt Ward, Mary H. Soegaard, Signe Holst Dwyer, Terence Hadassah Hebrew Univ Braun Sch Publ Hlth & Community Med POB 12000 IL-91120 Jerusalem Israel Hadassah Hebrew Univ Dept Hematol Jerusalem Israel Ohio State Univ Coll Publ Hlth Columbus OH 43210 USA Ohio State Univ Ctr Biostat Dept Biomed Informat Columbus OH 43210 USA Univ Melbourne Royal Childrens Hosp Murdoch Childrens Res Inst Melbourne Vic Australia NCI Div Canc Epidemiol & Genet Rockville MD USA Norwegian Inst Publ Hlth Ctr Fertil & Hlth Oslo Norway Statens Serum Inst Dept Epidemiol Res Ctr Fetal Programming Copenhagen Denmark Ohio State Univ Res Inst Dept Pediat Nationwide Childrens Hosp Columbus OH 43210 USA Ohio State Univ Dept Obstet & Gynecol Res Inst Nationwide Childrens Hosp Columbus OH 43210 USA Ohio State Univ Dept Epidemiol Res Inst Nationwide Childrens Hosp Columbus OH 43210 USA Univ Bristol Ctr Child & Adolescent Hlth Bristol Avon England Int Agcy Res Canc Epigenet Grp Lyon France Univ Oxford Nuffield Dept Obstet Gynaecol Womens Ctr Oxford England Heinrich Heine Univ Dusseldorf Univ Childrens Hosp Med Fac Dept Pediat Oncol Hematol & Clin Immunol Dusseldorf Germany Statens Serum Inst Dept Epidemiol Res Copenhagen Denmark Univ Oxford Nuffield Dept Obstet & Gynaecol George Inst Global Hlth Oxford England

The "delayed infection hypothesis" states that a paucity of infections in early childhood may lead to higher risks of childhood leukemia (CL), especially acute lymphoblastic leukemia (ALL). Using prospectively collected data from six population-based birth cohorts we studied the association between birth order (a proxy for pathogen exposure) and CL. We explored whether other birth or parental characteristics modify this association. With 2.2 x 10(6) person-years of follow-up, 185 CL and 136 ALL cases were ascertained. In Cox proportional hazards models, increasing birth order (continuous) was inversely associated with CL and ALL;hazard ratios (HR) = 0.88, 95% confidence interval (CI): (0.77-0.99) and 0.85: (0.73-0.99), respectively. Being later-born was associated with similarly reduced hazards of CL and ALL compared to being first-born;HRs = 0.78: 95% CI: 0.58-1.05 and 0.73: 0.52-1.03, respectively. Successive birth orders were associated with decreased CL and ALL risks (P for trend 0.047 and 0.055, respectively). Multivariable adjustment somewhat attenuated the associations. We found statistically significant and borderline interactions between birth weight (p = 0.024) and paternal age (p = 0.067), respectively, in associations between being later-born and CL, with the lowest risk observed for children born at <3 kg with fathers aged 35+ (HR = 0.18, 95% CI: 0.06-0.50). Our study strengthens the theory that increasing birth order confers protection against CL and ALL risks, but suggests that this association may be modified among subsets of children with different characteristics, notably advanced paternal age and lower birth weight. It is unclear whether these findings can be explained solely by infectious exposures.

关键词： childhood leukemia acute lymphoblastic leukemia birth order paternal age birth weight cohort studies

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In Vivo Optical Imaging of Myelination Events in a Myelin Basic Protein Promoter-Driven Luciferase Transgenic Mouse Model

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ASN NEURO 2018年第1期10卷 1759091418777329页

作者： Cao, James Hu, Yanping Shazeeb, Mohammed Salman Pedraza, Carlos E. Pande, Nilesh Weinstock, Daniel Polites, Gregory H. Zhang, Wenfei Chandross, Karen J. Ying, Xiaoyou Sanofi R&D Global Res Platform Translat Vivo Model 49 New York Ave Framingham MA 01701 USA Sanofi R&D Multiple Sclerosis Cluster Neurosci Res Framingham MA USA Janssen Res & Dev Spring House PA USA Regeneron Pharmaceut Tarrytown NY USA Sanofi R&D Biostat & Programming Framingham MA USA Strateg Initiat & Sci Relat Bridgewater NJ USA

The compact myelin sheath is important for axonal function, and its loss can lead to neuronal cell death and irreversible functional deficits. Myelin is vulnerable to a variety of metabolic, toxic, and autoimmune insults. In diseases like multiple sclerosis, there is currently no therapy to stop myelin loss, underscoring the need for neuroprotective and remyelinating therapies. Noninvasive, robust techniques are also needed to confirm the effect of such therapies in animal models. This article describes the generation, characterization, and potential uses for a myelin basic protein-luciferase (MBP-luci) transgenic mouse model, in which the firefly luciferase reporter gene is selectively controlled by the MBP promoter. In vivo bioluminescence imaging can be used to visualize and quantify demyelination and remyelination at the transcriptional level, noninvasively, and in real time. Transgenic mice were assessed in the cuprizone-induced model of demyelination, and luciferase activity highly correlated with demyelination and remyelination events as confirmed by both magnetic resonance imaging and postmortem histological analysis. Furthermore, MBP-luci mice demonstrated enhanced luciferase signal and remyelination in the cuprizone model after treatment with a peroxisome proliferator activated receptor-delta selective agonist and quetiapine. Imaging sensitivity was further enhanced by using CycLuc 1, a luciferase substrate, which has greater blood-brain barrier penetration. We demonstrated the utility of MBP-luci model in tracking myelin changes in real time and supporting target and therapeutic validation efforts.

关键词： CycLuc-1 firefly luciferase (luci) multiple sclerosis myelin basic protein myelination peroxisome proliferator activated receptor-delta

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Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

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CARDIOVASCULAR DIABETOLOGY 2019年第1期18卷 149-149页

作者： Ray, Kausik K. Del Prato, Stefano Mueller-Wieland, Dirk Cariou, Bertrand Colhoun, Helen M. Tinahones, Francisco J. Domenger, Catherine Letierce, Alexia Mandel, Jonas Samuel, Rita Bujas-Bobanovic, Maja Leiter, Lawrence A. Imperial Coll Dept Primary Care & Publ Hlth Imperial Ctr Cardiovasc Dis Prevent London SW7 2AZ England Univ Pisa Dept Clin & Expt Med Pisa Italy Univ Hosp Aachen Dept Internal Med Aachen Germany CHU Nantes INSERM Dept Endocrinol Inst Thorax F-1413 Nantes France Univ Edinburgh Edinburgh Midlothian Scotland Univ Malaga Hosp Virgen Victoria CIBER Fisiopatol Obesidad & Nutr CIBERobn Inst Salud Carlos IIIDept Clin Endocrinol & Nutr Malaga Spain Sanofi Gentilly France Sanofi Biostat & Programming Dept Chilly Mazarin France IviData Stats Levallois Perret France Regeneron Pharmaceut Inc New York NY USA Sanofi Paris France Univ Toronto St Michaels Hosp Li Ka Shing Knowledge Inst Toronto ON Canada

BackgroundIndividuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778).MethodsIn DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C >= 100 mg/dL;n=413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C >= 70 mg/dL;n=441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin<9% (DM-DYSLIPIDEMIA) or<10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was >= 70 mg/dL (DM-INSULIN) or non-HDL-C was >= 100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these *** analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C<100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA];65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB<80

关键词： Alirocumab Atherosclerotic cardiovascular disease Type 2 diabetes mellitus Low-density lipoprotein cholesterol Dyslipidemia

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Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis

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JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY 2019年第6期143卷 2170-2177页

作者： Steinfeld, Jonathan Bradford, Eric S. Brown, Judith Mallett, Stephen Yancey, Steven W. Akuthota, Praveen Cid, Maria C. Gleich, Gerald J. Jayne, David Khoury, Paneez Langford, Carol A. Merkel, Peter A. Moosig, Frank Specks, Ulrich Weller, Peter F. Wechsler, Michael E. GlaxoSmithKline Resp TAU & Flexible Discovery Unit Philadelphia PA USA GlaxoSmithKline Resp Therapeut Area Res Triangle Pk NC USA GlaxoSmithKline Res & Dev Immunoinflammat TAU Stockley Pk West Uxbridge Middx England GlaxoSmithKline Res & Dev Stat Programming & Data Stand Stockley Pk West Uxbridge Middx England Univ Calif San Diego Div Pulm Crit Care & Sleep Med La Jolla CA 92093 USA Univ Barcelona Dept Autoimmune Dis Hosp Clin Inst Invest Biomed August Pi I Sunyer IDIBAPS Barcelona Spain Univ Utah Sch Med Dept Dermatol Salt Lake City UT USA Univ Utah Sch Med Dept Med Salt Lake City UT USA Univ Cambridge Dept Med Cambridge England NIAID Human Eosinophil Sect Lab Parasit Dis NIH 9000 Rockville Pike Bethesda MD 20892 USA Cleveland Clin Dept Rheumat & Immunol Dis Ctr Vasculitis Care & Res Cleveland OH 44106 USA Univ Penn Div Rheumatol Dept Biostat Epidemiol & Informat Philadelphia PA 19104 USA Rheumazentrum Schleswig Holstein Mitte Neumunster Germany Mayo Clin Div Pulm & Crit Care Med Rochester MN USA Harvard Med Sch Dept Med Beth Israel Deaconess Med Ctr Div Allergy Boston MA 02115 USA Harvard Med Sch Dept Med Beth Israel Deaconess Med Ctr Div Infect Dis Boston MA 02115 USA Natl Jewish Hlth Dept Med 1400 Jackson St Denver CO 80230 USA

Background: In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated versus 19% of placebo-treated patients with eosinophilic granulomatosis with polyangiitis (EGPA) achieved protocol-defined remission. Objective: We sought to investigate post hoc the clinical benefit of mepolizumab in patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses. Methods: The randomized, placebo-controlled, double-blind, parallel-group trial recruited patients with relapsing/refractory EGPA receiving stable OGCs (prednisolone/prednisone, >= 7.5-50 mg/d) for 4 or more weeks. Patients received 300 mg of subcutaneous mepolizumab or placebo every 4 weeks for 52 weeks. Clinical benefit was defined post hoc as follows: remission at any time (2 definitions used), 50% or greater OGC dose reduction during weeks 48 to 52, or no EGPA relapses. The 2 remission definitions were Birmingham Vasculitis Activity Score of 0 plus OGC dose of 4 mg/d or less (remission 1/clinical benefit 1) or 7.5 mg/d or less (remission 2/clinical benefit 2). Clinical benefit was assessed in all patients and among subgroups with a baseline blood eosinophil count of less than 150 cells/mL, baseline OGC dosage of greater than 20 mg/d, or weight of greater than 85 kg. Results: With mepolizumab versus placebo, 78% versus 32% of patients experienced clinical benefit 1, and 87% versus 53% of patients experienced clinical benefit 2 (both P < .001). Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/mL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005);in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395). Conclusion: When a comprehensive definition of clinical benefit was applied to data from a randomized controlled trial, 78% to 87% of

关键词： Eosinophilic granulomatosis with polyangiitis Churg-Strauss syndrome mepolizumab eosinophils IL-5 vasculitis

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ALEXANDRA/IMpassion030: A phase III study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer

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ANNALS OF ONCOLOGY 2019年 30卷 97-97页

作者： Ignatiadis, M. McArthur, H. L. Bailey, A. Martinez, J. de Azambuja, E. Metzger, O. Lai, C. Franzoi, M. A. Goulioti, T. Daly, F. Bouhlel, A. Balta, V. Maetens, M. Viale, G. Andre, B. DuFRane, C. Nguyen, D. A. Gelber, R. D. Piccart, M. Winer, E. P. Inst Jules Bordet Med Oncol Brussels Belgium Cedars Sinai Med Ctr Samuel Oschin Comprehens Canc Inst Los Angeles CA 90048 USA Frontier Sci Biostat Kingussie Scotland Breast Int Grp Med Brussels Belgium Dana Farber Canc Inst Breast Oncol Boston MA 02115 USA Genentech Inc Global Dev Team San Francisco CA USA Inst Jules Bordet Clin Trial Support Unit Brussels Belgium Breast Int Grp Clin Res CEO Brussels Belgium Frontier Sci Scotland Stat & Programming Kingussie Scotland Roche Global Dev Team Basel Switzerland Breast Int Grp Project Management Brussels Belgium Ist Europeo Oncol Pathol Milan Italy Inst Jules Bordet Clin Trial Support Unit Brussels Belgium Alliance Fdn Trials LLC Clin Trial Operat Boston MA USA Dana Farber Canc Inst Biostat Boston MA 02115 USA Inst Jules Bordet Med Brussels Belgium Harvard Med Sch Med Boston MA 02115 USA

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The differential impact of maternal dietary macronutrient composition on offspring birthweight - results from the Danish National Birth Cohort

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PROCEEDINGS OF THE NUTRITION SOCIETY 2018年第OCE4期77卷 E183-E183页

作者： Sharma, S. S. Greenwood, D. C. Granstrom, C. Simpson, N. A. B. Olsen, S. F. Cade, J. E. Univ Leeds Sch Food Sci & Nutr Nutr Epidemiol Grp Leeds LS2 9JT W Yorkshire England Univ Leeds Div Biostat Leeds LS2 9JT W Yorkshire England Univ Leeds Div Obstet & Gynaecol Leeds LS2 9JT W Yorkshire England Statens Serum Inst Dept Epidemiol Res Ctr Fetal Programming Copenhagen Denmark

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Lack of Association Between Maternal or Neonatal Vitamin D Status and Risk of Childhood Type 1 Diabetes: A Scandinavian Case-Cohort Study

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AMERICAN JOURNAL OF EPIDEMIOLOGY 2018年第6期187卷 1174-1181页

作者： Thorsen, Steffen U. Marild, Karl Olsen, Sjurdur F. Holst, Klaus K. Tapia, German Granstrom, Charlotta Halldorsson, Thorhallur I. Cohen, Arieh S. Haugen, Margaretha Lundqvist, Marika Skrivarhaug, Torild Njolstad, Pal R. Joner, Geir Magnus, Per Stordal, Ketil Svensson, Jannet Stene, Lars C. Statens Serum Inst Dept Epidemiol Res Ctr Fetal Programming Copenhagen Denmark Herlev & Gentofte Univ Hosp Dept Pediat Copenhagen Diabet Res Ctr Herlev Denmark Univ Copenhagen Fac Hlth & Med Sci Copenhagen Denmark Norwegian Inst Publ Hlth Oslo Norway Univ Colorado Barbara Davis Ctr Aurora CO USA Harvard TH Chan Sch Publ Hlth Boston MA USA Univ Copenhagen Sect Biostat Dept Publ Hlth Copenhagen Denmark Univ Iceland Sch Hlth Sci Fac Food Sci & Nutr Unit Nutr Res Reykjavik Iceland Statens Serum Inst Dept Congenital Disorders Copenhagen Denmark Oslo Univ Hosp Div Pediat & Adolescent Med Oslo Norway Univ Bergen Dept Clin Sci KG Jebsen Ctr Diabet Res Bergen Norway Haukeland Hosp Dept Pediat Bergen Norway Univ Oslo Inst Clin Med Oslo Norway

Studies on vitamin D status during pregnancy and risk of type 1 diabetes mellitus (T1D) lack consistency and are limited by small sample sizes or single measures of 25-hydroxyvitamin D (25(OH)D). We investigated whether average maternal 25(OH)D plasma concentrations during pregnancy are associated with risk of childhood T1D. In a case-cohort design, we identified 459 children with T1D and a random sample (n = 1,561) from the Danish National Birth Cohort (n = 97, 127) and Norwegian Mother and Child Cohort Study (n = 113,053). Participants were born between 1996 and 2009. The primary exposure was the estimated average 25(OH)D concentration, based on serial samples from the first trimester until delivery and on umbilical cord plasma. We estimated hazard ratios using weighted Cox regression adjusting for multiple confounders. The adjusted hazard ratio for T1D per 10-nmol/L increase in the estimated average 25(OH)D concentration was 1.00 (95% confidence interval: 0.90, 1.10). Results were consistent in both cohorts, in multiple sensitivity analyses, and when we analyzed mid-pregnancy or cord blood separately. In conclusion, our large study demonstrated that normal variation in maternal or neonatal 25(OH)D is unlikely to have a clinically important effect on risk of childhood T1D.

关键词： adolescent child diabetes mellitus type 1 etiology immunology vitamin D

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