Calcium and Vitamin D Fortified Products for the Optimization of Bone Health

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

2. Dr. James McClung/(508) 233-4979 Slide 2 of 21 25 October 2016
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.
Disclaimer

3. Dr. James McClung/(508) 233-4979 Slide 3 of 21 25 October 2016
 USARIEM overview
 Bone health/stress fracture
 Scientific evidence
 Recommendation
 Current status/way forward
Presentation Objectives

4. Dr. James McClung/(508) 233-4979 Slide 4 of 21 25 October 2016
USARIEM
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.
USARIEM is a subordinate command of the US
Army Medical Department’s Medical Research
and Materiel Command (USAMRMC)

5. Dr. James McClung/(508) 233-4979 Slide 5 of 21 25 October 2016
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
Objective: Define Warfighter nutritional requirements

6. Dr. James McClung/(508) 233-4979 Slide 6 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 7 of 21 25 October 2016
A Unique Nutrient
Sources:
 UV exposure
 Diet
25(OH)D is the
circulating form
regardless of source
RDA = 600 IU

8. Dr. James McClung/(508) 233-4979 Slide 8 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 9 of 21 25 October 2016
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)

10. Dr. James McClung/(508) 233-4979 Slide 10 of 21 25 October 2016
Phlebotomy Teams
 Credentialed staff
 Multiple stations
Mobile Biochemistry Lab
 On-site assays
 Sample prep
Data Collection
Goal: Quality Data, Minimal Footprint

11. Dr. James McClung/(508) 233-4979 Slide 11 of 21 25 October 2016
The Evidence: Stress Fracture
Stress Fractures by Site
Treatment = 800 IU Vitamin D,
2000 mg/Ca; n >5,000
Dietary Supplement
Female Sailors during Navy initial military training
Lappe et al. 2008
Calcium/vitamin D supplement
protects against stress fracture

12. Dr. James McClung/(508) 233-4979 Slide 12 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 13 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 14 of 21 25 October 2016
0
500
1000
1500
2000
2500
3000
Placebo Ca + Vit D
Pre
Post 0
500
1000
1500
2000
2500
3000
3500
4000
4500
Placebo Ca + Vit D
600 IU
DRI
1000-1300 mg
mDRI
2500-3000 mg
TUL
4000 IU
TUL
Total Calcium Intake, mg Total Vitamin D Intake, IU
Dietary intake of vitamin D is poor before and during IMT
The Evidence: Dietary Intake

15. Dr. James McClung/(508) 233-4979 Slide 15 of 21 25 October 2016
1.14
1.16
1.18
1.2
1.22
1.24
1.26
1.28
1.3
1.32
Pre Post
iCa(mmol/L)
a,b a,b
The Evidence: Biochemistry
Intervention improved calcium status and stabilized PTH
Gaffney-Stomberg et al., 2014

16. Dr. James McClung/(508) 233-4979 Slide 16 of 21 25 October 2016
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)
Pre
Post
120 ± 46
124 ± 46
139 ± 55
140 ± 52
T
2Cortical Content
(mg/mm)
Pre
Post
209 ± 46
213 ± 46#
219 ± 53
220 ± 52
T, T x G
2Cortical
Thickness (mm)
Pre
Post
2.86 ± 0.52
2.92 ± 0.52#
2.84 ± 0.60
2.85 ± 0.60
T, T x G
The Evidence: Bone Health
Calcium and vitamin D improved bone adaptation to BCT

17. Dr. James McClung/(508) 233-4979 Slide 17 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 18 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 19 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 20 of 21 25 October 2016
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. Dr. James McClung/(508) 233-4979 Slide 21 of 21 25 October 2016
Contact Information
James McClung, Ph.D.
James.P.McClung8.civ@mail.mil