Biomarkers of vitamin B-12 status in NHANES: a roundtable summary123456

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A roundtable to discuss the measurement of vitamin B-12 (cobalamin) status biomarkers in NHANES took place in July 2010. NHANES stopped measuring vitamin B-12–related biomarkers after 2006. The roundtable reviewed 3 biomarkers of vitamin B-12 status used in past NHANES—serum vitamin B-12, methylmalonic acid (MMA), and total homocysteine (tHcy)—and discussed the potential utility of measuring holotranscobalamin (holoTC) for future NHANES. The roundtable focused on public health considerations and the quality of the measurement procedures and reference methods and materials that past NHANES used or that are available for future NHANES. Roundtable members supported reinstating vitamin B-12 status measures in NHANES. They noted evolving concerns and uncertainties regarding whether subclinical (mild, asymptomatic) vitamin B-12 deficiency is a public health concern. They identified the need for evidence from clinical trials to address causal relations between subclinical vitamin B-12 deficiency and adverse health outcomes as well as appropriate cutoffs for interpreting vitamin B-12–related biomarkers. They agreed that problems with sensitivity and specificity of individual biomarkers underscore the need for including at least one biomarker of circulating vitamin B-12 (serum vitamin B-12 or holoTC) and one functional biomarker (MMA or tHcy) in NHANES. The inclusion of both serum vitamin B-12 and plasma MMA, which have been associated with cognitive dysfunction and anemia in NHANES and in other population-based studies, was preferable to provide continuity with past NHANES. Reliable measurement procedures are available, and National Institute of Standards and Technology reference materials are available or in development for serum vitamin B-12 and MMA.

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From the Office of Dietary Supplements, National Institutes of Health, Bethesda, MD (EAY, RLB, CS, PMC, and MFP); the National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA (CMP); the Analytical Chemistry Division, National Institute of Standards and Technology, Gaithersburg, MD (KWP); the Haematology Department, United Kingdom National External Quality Assessment Service, Sutton Coldfield, United Kingdom (SB); the Department of Pathology, Stony Brook University Medical Center, Stony Brook, NY (JLB); Genome Technology Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD (LCB); the Department of Medicine, New York Methodist Hospital, Brooklyn, NY (RC); Weill Medical College, Cornell University, New York, NY (RC); the National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, MD (LRC, DAL, and CLJ); the Department of Preventive Medicine and Epidemiology, Loyola University Chicago Stritch School of Medicine, Maywood, IL (RAD-A); the Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN (JHE); the Department of Medical Pathology and Laboratory Medicine and Medicine, University of California Davis, Sacramento, CA (RG); the Food Science and Human Nutrition Department, University of Florida, Gainesville, FL (JFG); the Department of Laboratory Medicine, University of Washington, Seattle, WA (ANH); the Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH (DWJ); the Department of Cell Biology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH (DWJ); Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA (PFJ and JS); the Department of Clinical Medicine, School of Medicine, Trinity College, Dublin, Ireland (AMM); Department of Biostatistics, Boston University School of Public Health, Boston, MA (JM); Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (JLM); the Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark (EN); the Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD (JIR); the Department of Nutritional Science and Toxicology, University of California, Berkeley, CA (BS); the Department of Medicine/Division of Hematology, University of Colorado Health Sciences Center, Aurora, CO (SS); the Division of Nutritional Sciences, Cornell University, Ithaca, NY (PS); the Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL (TT); Nutrition Science and Delivery, Department of Health, London, United Kingdom (AT); and the National Institute for Biological Standards and Control, Herts, United Kingdom (SJT).

2

The authors dedicate this article and the roundtable to Mary Frances Picciano, Office of Dietary Supplements, National Institutes of Health, who was the driving force behind this effort prior to her death in August 2010.

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Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the Centers for Disease Control and Prevention (CDC), the NIH, the US Department of Health and Human Services (DHHS), or the National Institute of Standards and Technology (NIST) or any of the authors’ related affiliations. Certain commercial equipment, instruments, or materials are identified in this article to specify adequately the experimental procedure. Such identification does not imply recommendation or endorsement by the NIST, the CDC, the NIH or the DHHS, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose.

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Supported by the National Center for Health Statistics, Centers for Disease Control and Prevention, and Office of Dietary Supplements, National Institutes of Health.

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Address reprint requests to PM Coates, Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, MSC 7517, Bethesda, MD 20892-7517. E-mail: [email protected].

6

Address correspondence to EA Yetley (retired), Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, MSC 7517, Bethesda, MD 20892-7517. E-mail: [email protected].

Copyright © 2011 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.