1. 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

2. 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 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 and 32 CFR 219 on the use of volunteers in research.

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

4. 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.

5. 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

6. 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

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

8. 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

9. 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 (Navy)
Gaffney-Stomberg, McClung, et al (Army)
Gaffney-Stomberg, McClung, et al (Air Force)
Gaffney-Stomberg, McClung, et al (Marines)

10. 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

11. 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

12. 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

13. 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!

14. The Evidence: Dietary Intake
Total Calcium Intake, mg
Total Vitamin D Intake, IU mg
TUL
4000 IU
TUL mg
mDRI
600 IU DRI
Dietary intake of vitamin D is poor before and during IMT

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

16. 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

17. 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

18. 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

19. 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

20. 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

21. Contact Information
James McClung, Ph.D.