Thomas A. Barringer, MD; Julienne K. Kirk, PharmD; Amy C. Santaniello, PharmD; Kristie Long Foley, PhD; Robert Michielutte, PhD
Acknowledgments: The authors thank Dave Reboussin, PhD, for his assistance in the statistical analysis. Dr. Barringer thanks Geraldine D. Anastasio, PharmD, his original co-investigator who initiated the research project, for her enthusiasm and encouragement to continue the study in her absence.
Grant Support: By the Charlotte-Mecklenburg Health Services Foundation, an independent, charitable foundation that supports medical education and research within the Carolinas HealthCare System.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Thomas A. Barringer, MD, Department of Family Practice, Carolinas Medical Center, CMC-MP Building, 1350 South Kings Drive, Charlotte, NC 28207; e-mail, email@example.com.
Current Author Addresses: Dr. Barringer: Department of Family Practice, Carolinas Medical Center, CMC-MP Building, 1350 South Kings Drive, Charlotte, NC 28207.
Drs. Kirk and Michielutte: Department of Family Medicine, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157.
Dr. Santaniello: 8918 Waltham Forest Court, Waxhaw, NC 28173.
Dr. Foley: Department of Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157.
Author Contributions: Conception and design: T.A. Barringer, J.K. Kirk.
Analysis and interpretation of the data: T.A. Barringer, J.K. Kirk, K.L. Foley, R. Michielutte.
Drafting of the article: T.A. Barringer, J.K. Kirk, A.C. Santaniello, K.L. Foley.
Critical revision of the article for important intellectual content: T.A. Barringer, J.K. Kirk, K.L. Foley, R. Michielutte.
Final approval of the article: T.A. Barringer, J.K. Kirk, A.C. Santaniello, R. Michielutte.
Provision of study materials or patients: T.A. Barringer, J.K. Kirk, A.C. Santaniello.
Statistical expertise: T.A. Barringer, K.L. Foley, R. Michielutte.
Obtaining of funding: T.A. Barringer.
Administrative, technical, or logistic support: T.A. Barringer, J.K. Kirk.
Collection and assembly of data: T.A. Barringer, J.K. Kirk, A.C. Santaniello.
Use of multivitamin and mineral supplements is common among U.S. adults, yet few well-designed trials have assessed the reputed benefits.
To determine the effect of a daily multivitamin and mineral supplement on infection and well-being.
Randomized, double-blind, placebo-controlled trial.
Primary care clinics at two medical centers in North Carolina.
130 community-dwelling adults stratified by age (45 to 64 years or 65 years) and presence of type 2 diabetes mellitus.
Multivitamin and mineral supplement or placebo taken daily for 1 year.
Incidence of participant-reported symptoms of infection, incidence of infection-associated absenteeism, and scores on the physical and mental health subscales of the Medical Outcomes Study 12-Item Short Form.
More participants receiving placebo reported an infectious illness over the study year than did participants receiving multivitamin and mineral supplements (73% vs. 43%; P < 0.001). Infection-related absenteeism was also higher in the placebo group than in the treatment group (57% vs. 21%; P < 0.001). Participants with type 2 diabetes mellitus (n = 51) accounted for this finding. Among diabetic participants receiving placebo, 93% reported an infection compared with 17% of those receiving supplements (P < 0.001). Medical Outcomes Study 12-Item Short Form scores did not differ between the treatment and placebo groups.
A multivitamin and mineral supplement reduced the incidence of participant-reported infection and related absenteeism in a sample of participants with type 2 diabetes mellitus and a high prevalence of subclinical micronutrient deficiency. A larger clinical trial is needed to determine whether these findings can be replicated not only in diabetic persons but also in any population with a high rate of suboptimal nutrition or potential underlying disease impairment.
Forty percent of U.S. adults use vitamin and mineral supplements, yet evidence of the health benefits of these supplements is lacking. The purported benefits of supplements relate to the immune system.
In this randomized, controlled trial, participants taking multivitamin and mineral supplements reported fewer infections and days absent from work than participants taking placebo. The results were largely due to striking benefits in participants with type 2 diabetes mellitus.
Multivitamin and mineral supplements appear to reduce infections in people with type 2 diabetes mellitus, a group at risk for micronutrient deficiency.
Flow of participants through the study.
Table 1. Supplement Formulation
Table 2. Baseline Demographic Characteristics and Clinical, Stress, Health Behavior, and Quality-of-Life Data according to Study Group
Table 3. Effect of a Multivitamin and Mineral Supplement on Infection Incidence and Infection-Related Absenteeism according to Diabetes Status and Age
Table 4. Nutritional Deficiency among Subgroups of Diabetes Status and Age
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Barringer TA, Kirk JK, Santaniello AC, et al. Effect of a Multivitamin and Mineral Supplement on Infection and Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2003;138:365–371. doi: 10.7326/0003-4819-138-5-200303040-00005
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Published: Ann Intern Med. 2003;138(5):365-371.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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