Military Nutrition Division Calcium and Vitamin D Fortified Products for the Optimization of Bone Health James McClung, Ph.D. Military Nutrition Division US Army Research Institute of Environmental Medicine (USARIEM), Natick, MA USA

Disclaimer The opinions or assertions contained herein are the private views of the authors are not to be construed as official or as reflecting the views of the Army or Department of Defense. Any citations of commercial organizations and trade names in this report do not constitute an official Department of the Army endorsement of approval of the products or services of these organizations. The investigators have adhered to the policies for protection of human subjects as prescribed in DOD Instruction 3216.02 and the research was conducted in adherence with the provisions of 32 CFR Part 219. Human subjects participated in these studies after giving their free and informed voluntary consent. Investigators adhered to DoD Instruction 3216.02 and 32 CFR 219 on the use of volunteers in research.

Presentation Objectives USARIEM overview Bone health/stress fracture Scientific evidence Recommendation Current status/way forward

USARIEM USARIEM is a subordinate command of the US Army Medical Department’s Medical Research and Materiel Command (USAMRMC) MISSION: USARIEM provides solutions to optimize Warfighter health and performance through medical research. VISION: To be recognized by the DoD as the trusted leader in medical research for Warfighter health and performance optimization.

Military Nutrition Division MISSION: Conduct research that provides a biomedical science basis for developing new rations, menus, policies and programs that enable Warfighter health-readiness and optimal performance. Research Thrusts: Recovery Nutrition Healthy Eating Dietary Supplements Physiological Resilience Table 1 should be populated by the PM; these numbers should be pulled from the budget sheets for FY10 and FY11. Table 2 should be populated by the TAM. Double check that the numbers from the MOMRP website match the tables. Objective: Define Warfighter nutritional requirements

Calcium, Vitamin D and Bone Health Deficiency results in impaired mineralization Rickets in children Osteomalacia in adults Weakened bones are at increased risk for fracture Primary function of vitamin D: calcium absorption

A Unique Nutrient RDA = 600 IU Sources: UV exposure Diet 25(OH)D is the circulating form regardless of source RDA = 600 IU

Stress Fracture Stress fracture is up to 18 times more frequent in trainees compared to active service members Up to 2-5% of males and 8-21% of females may sustain a stress fracture during BCT McClung & Karl, 2009

Research Studies have assessed the efficacy of calcium/vitamin D for prevention of stress fracture and optimization of bone health in the Initial Entry Training (IET) environment: Lappe et al. 2008 (Navy) Gaffney-Stomberg, McClung, et al. 2012 (Army) Gaffney-Stomberg, McClung, et al. 2013 (Air Force) Gaffney-Stomberg, McClung, et al. 2013 (Marines)

Goal: Quality Data, Minimal Footprint Data Collection Phlebotomy Teams Credentialed staff Multiple stations Mobile Biochemistry Lab On-site assays Sample prep Goal: Quality Data, Minimal Footprint

The Evidence: Stress Fracture Female Sailors during Navy initial military training Treatment = 800 IU Vitamin D, 2000 mg/Ca; n >5,000 Dietary Supplement Stress Fractures by Site Calcium/vitamin D supplement protects against stress fracture Lappe et al. 2008

Army Intervention Male and female Soldiers undergoing Army IET 2000 mg Ca, 1000 IU vitamin D daily through training; 2 bars per day Peripheral quantitative computed tomography (pQCT) of the tibia, circulating nutrition and bone biomarkers

The Evidence: Pill vs. Snack First iteration: 5 pills daily with meals 67% attrition 77-83% compliance in those who completed the trial Second iteration: 2 snack bars daily between meals 32% attrition 81-88% compliance Soldiers prefer snacks!

The Evidence: Dietary Intake Total Calcium Intake, mg Total Vitamin D Intake, IU 2500-3000 mg TUL 4000 IU TUL 1000-1300 mg mDRI 600 IU DRI Dietary intake of vitamin D is poor before and during IMT

The Evidence: Biochemistry a,b Intervention improved calcium status and stabilized PTH Gaffney-Stomberg et al., 2014

The Evidence: Bone Health Ca + Vit D n = 26 Placebo n = 21 Effect 1Total Density (mg/cm3) Pre Post 338 ± 52 347 ± 49# 346 ± 55 350 ± 52 T, T x G 1Bone Strength Index Total (mg/mm4) 120 ± 46 124 ± 46 139 ± 55 140 ± 52 T 2Cortical Content (mg/mm) 209 ± 46 213 ± 46# 219 ± 53 220 ± 52 2Cortical Thickness (mm) 2.86 ± 0.52 2.92 ± 0.52# 2.84 ± 0.60 2.85 ± 0.60 Calcium and vitamin D improved bone adaptation to BCT

Summary from Evidence Stress fracture is a significant military problem Vitamin D intake is poor before/during training Calcium/vitamin D supplementation reduces incidence of stress fracture Calcium/vitamin D fortified food product improves nutritional status, bone health

Dilemma Dilemma: Should nutrients be provided at levels beyond mDRI? Who implements research? Recommendation (near term): Provide Warfighters access to fortified snack during initial training? Current status: Implementation of fortified snack to begin during Army IET 2016/2017

Way Forward Joint team (CFD, USARIEM, JCCoE, OTSG) makes recommendation to TRADOC regarding fortified food product CFD manufactures test products DLA acquires industry product Implementation Program evaluation for efficacy

Acknowledgements Soldier volunteers ARIEM study staff Dr. Erin Gaffney-Stomberg Ms. Laura Lutz Combat Feeding Directorate Ms. Betty Davis Mr. Paul Maguire Pennington Biomedical Research Center TRADOC COL Sonya Cable OTSG DLA staff Potential industry partners

Contact Information James McClung, Ph.D. James.P.McClung8.civ@mail.mil