Status:
COMPLETED
Calcium Kinetic Responses to Exercise
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
Cornell University
Conditions:
Nutritional Status
Bones
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief Summary
This randomized cross-over study will identify physiological factors that underlie changes in bone metabolism that could affect skeletal injury risk, to include increases in parathyroid hormone (PTH) ...
Detailed Description
Initial military training (IMT) results in increased risk of stress fracture, particularly for females as up to 21% of females may sustain a stress fracture during IMT, an incidence that is approximat...
Eligibility Criteria
Inclusion
- Women aged 18-42 years
- No current or prior military service
- Exercise 2-5 x/wk
- Stable body weight for 2 months (±5 lbs)
- Body mass index (BMI) between 19-26 kg/m2
- VO2max between 35-50 ml·kg-1·min-1
- Willing to discontinue use of dietary supplements and abstain from alcohol for the duration of the study
- Have not donated blood within the last 8 weeks
Exclusion
- History of endocrine disorders (e.g., diabetes, uncontrolled thyroid dysfunction, hypoparathyroidism, or hyperparathyroidism)
- History of bone-modifying disorders (e.g., osteogenesis imperfecta, osteopetrosis, or rickets)
- History of cardiovascular or renal disease
- Pregnancy or lactation in the last 6 months
- Routine use of medications known to affect bone or calcium metabolism (e.g., thiazide diuretics, bisphosphonates, oral steroids)
- A very restrictive diet or severe food allergies
Key Trial Info
Start Date :
June 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03293901
Start Date
June 16 2018
End Date
March 18 2020
Last Update
December 21 2022
Active Locations (1)
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1
United States Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760