Use of Dietary Supplements by Military Personnel

Preface......Page 11
Contents......Page 15
Summary......Page 17
APPROACH TO MANAGE THE USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL......Page 18
Improving Monitoring of the Use of Dietary Supplements by Military Personnel......Page 19
Using a Framework to Characterize Concern Level for Dietary Supplements in a Military Context......Page 21
Implementing an Adverse Event Surveillance System......Page 23
Expanding Education: Training and Outreach......Page 25
Approaches to Identifying Research Needs......Page 27
COMMITTEE’S TASK AND APPROACH......Page 29
Approach of the Committee: Definitions and Collection and Analysis of Data......Page 30
USE AND MANAGEMENT OF DIETARY SUPPLEMENTS IN THE UNITED STATES......Page 34
MILITARY’S INTEREST IN MANAGING DIETARY SUPPLEMENT USE......Page 37
Heightened Performance Requirements......Page 38
Perceptions About Safety of Dietary Supplements Products Sold at Installations......Page 39
Specific Subpopulations Within the Military......Page 40
Current Military Policies to Manage Dietary Supplement Use......Page 41
REFERENCES......Page 43
INTRODUCTION......Page 45
Overall Use and Behavioral Patterns......Page 52
Single Vitamin/Mineral Supplement Use......Page 53
Ergogenic/Health Enhancement Dietary Supplements......Page 54
Differences in Supplement Use by Demographic Factors......Page 56
Behavioral Patterns......Page 57
Adverse Events......Page 58
RECOMMENDATIONS FOR CONDUCTING SURVEYS......Page 60
Monitoring Surveys: Overall Recommendations......Page 61
Planning Stage: Recommendations for Better Survey Designs......Page 64
Questions on health and performance......Page 70
Administration Stage: Recommendations for Data Collection......Page 71
REFERENCES......Page 73
INTRODUCTION......Page 75
Risks of Vitamin and Mineral Deficiencies......Page 77
Upper Limits as Safety Levels for Vitamins and Minerals......Page 78
Are There Safety Concerns for Vitamin and Mineral Use Among Military Populations?......Page 79
RESEARCH NEEDS......Page 81
REFERENCES......Page 83
INTRODUCTION......Page 85
Background......Page 88
Update on IOM Caffeine Report (2001)—Safety Concerns......Page 90
Considerations Specific to the Military......Page 92
REFERENCES......Page 95
Background......Page 97
Safety Concerns......Page 98
Considerations Specific to the Military......Page 99
REFERENCES......Page 104
Putative Benefits......Page 106
Safety Concerns......Page 107
Considerations Specific to the Military......Page 108
REFERENCES......Page 124
Putative Benefits......Page 126
Considerations Specific to the Military......Page 127
REFERENCES......Page 138
Background......Page 140
Safety Concerns......Page 141
Considerations Specific to the Military......Page 142
REFERENCES......Page 164
Background......Page 167
Safety Concerns......Page 168
Considerations Specific to the Military......Page 169
REFERENCES......Page 176
Putative Benefits......Page 177
Safety Concerns......Page 179
Considerations Specific to the Military......Page 180
REFERENCES......Page 194
Putative Benefits......Page 196
Safety Concerns......Page 198
Considerations Specific to the Military.......Page 199
REFERENCES......Page 208
Putative Benefits......Page 210
Considerations Specific to the Military......Page 211
REFERENCES......Page 218
Putative Benefits......Page 219
Considerations Specific to the Military......Page 220
REFERENCES......Page 224
Putative Benefits......Page 225
Safety Concerns......Page 226
Considerations Specific to the Military......Page 227
REFERENCES......Page 230
Putative Benefits......Page 231
Considerations Specific to the Military......Page 232
REFERENCES......Page 236
Putative Benefits......Page 237
Considerations Specific to the Military......Page 238
REFERENCES......Page 242
Safety Concerns......Page 243
Considerations Specific to the Military......Page 244
REFERENCES......Page 250
Safety Concerns......Page 251
Considerations Specific to the Military......Page 252
REFERENCES......Page 256
BACKGROUND......Page 257
SAFETY FRAMEWORK FOR DIETARY SUPPLEMENTS: MODIFICATIONS FOR MILITARY USE......Page 260
Initial Review of Signals......Page 261
Integrated Safety Evaluation......Page 266
Decision to Take Action......Page 271
Education......Page 274
CHALLENGES OF THE PROPOSED FRAMEWORK FOR MILITARY PERSONNEL......Page 285
OVERALL RECOMMENDATIONS......Page 286
REFERENCES......Page 288
BACKGROUND......Page 289
THE FDA’S PROCESS TO MONITOR ADVERSE EVENTS FROM DIETARY SUPPLEMENTS......Page 291
Quality of data collected......Page 293
Military Adverse Event Monitoring System for Medications......Page 295
Military Policies on Reporting of Advese Events and Use of Dietary Supplements......Page 296
Low reporting rate in the military......Page 298
Quality of data collected......Page 299
PROPOSED ADVERSE EVENT SURVEILLANCE SYSTEM FOR DIETARY SUPPLEMENTS FOR THE MILITARY......Page 300
Recommendations for the Collection and Analysis of Adverse Event Data......Page 302
Develop and implement reporting mechanisms......Page 305
Review of adverse events associated with dietary supplement use......Page 307
Recommendation to Share Adverse Events Data and Other Information Related to Dietary Supplements......Page 308
Actively pursue outreach activities......Page 310
Provide appropriate training and continuing education for health care personnel......Page 311
REFERENCES......Page 312
7: Research Needs......Page 315
Animal Models......Page 316
Identification of Research Needs for Specific Dietary Supplements......Page 317
POTENTIAL RESEARCH AREAS OF INTEREST......Page 319
Research on Beneficial Effects from Supplements Relevant to the Military......Page 320
Research on Education Methods......Page 321
REFERENCES......Page 322
A:
Workshop Agenda......Page 323
Military Demographics......Page 327
Energy Cost of Military Activities......Page 328
Dietary Practices of Military Personnel......Page 330
Do Military Personnel Need Nutritional Supplements?......Page 331
Summary......Page 332
REFERENCES......Page 334
Department of Defense Interest in the Operational Use of Dietary Supplements—Impact of the Dietary Supplements Health and Education Act (DSHEA)......Page 335
FINDINGS OF AN INTERNATIONAL DEFENSE PANEL ON DIETARY SUPPLEMENTS......Page 337
Why Have So Few Dietary Supplements Been Found to Be Effective?......Page 348
Acknowledgements......Page 349
REFERENCES......Page 350
DISCUSSION AND CONCLUSIONS......Page 354
SUGGESTIONS FOR FUTURE IMPROVEMENTS......Page 355
Additional Resources......Page 357
Survey Information......Page 358
Technical Aspects of Survey Conduct......Page 359
The Slone Survey: An Example of Survey Design and Conduct......Page 361
REFERENCES......Page 365
Methods......Page 366
Statistical Analyses......Page 367
Discussion......Page 371
REFERENCE......Page 373
Supplement Usage Among Military and Nonmilitary......Page 375
Profile of Military Supplement Users......Page 377
Regression Analysis of Dietary Supplement Usage......Page 379
Conclusions......Page 380
BEYOND THE DFAC (DINING FACILITY): WHAT SUPPLEMENTS SOLDIERS ARE TAKING AND WHY......Page 381
Review of Literature......Page 385
Experimental Results......Page 386
Discussions and Conclusions......Page 387
REFERENCES......Page 392
INTRODUCTION......Page 393
Methods......Page 394
Results......Page 397
Discussion......Page 408
REFERENCES......Page 410
ACKNOWLEDGEMENTS......Page 413
SURVEY OF ARMY HEALTH CARE PROVIDERS CONCERNING DIETARY SUPPLEMENTS......Page 415
INTRODUCTION......Page 421
Methods......Page 422
Survey Administration......Page 423
Results......Page 424
Discussion......Page 434
Acknowledgements......Page 435
REFERENCES......Page 436
Regulatory Background......Page 439
The Safety Framework......Page 441
Integrating the data to determine risk......Page 443
Key Principles for Considering Data......Page 445
APPROACHES FOR POSTMARKETING ADVERSE EFFECT SURVEILLANCE OF DRUGS AND BIOLOGICALS......Page 448
REFERENCES......Page 454
FDA POSTMARKETING SURVEILLANCE: ISSUES FOR DIETARY SUPPLEMENTS......Page 455
INTRODUCTION......Page 458
Existing Systems of Postmarket Surveillance for Consumer Products and Sponsoring Agencies or Organizations......Page 459
AER Challenges and Opportunities for Supplement Manufacturers and Their Customers......Page 464
Final Comments Regarding Supplements, Botanicals, and AERs......Page 466
REFERENCES......Page 467
C: Findings from Recent Surveys on Dietary Supplement Use by Military Personnel and the General Population......Page 469
REFERENCES......Page 485
THE CASE OF DEHYDROEPIANDROSTERONE: DECISIONS FOR ACTION......Page 489
THE CASE OF EPHEDRA: DECISIONS FOR ACTION......Page 490
THE CASE OF MELATONIN: DECISIONS FOR ACTION......Page 492
REFERENCES......Page 493
E: Adverse Event Reporting Forms......Page 495
F: Biographical Sketches of Workshop Speakers......Page 503
G: Biographical Sketches of Committee Members......Page 511
H: Acronyms and Abbreviations......Page 517
I: Glossary......Page 521