Bone Health Clinical Trial
— MCRD-PIOfficial title:
Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo.
Status | Completed |
Enrollment | 380 |
Est. completion date | October 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 17 Years and older |
Eligibility |
Inclusion Criteria: - Male or female Marine Corps recruit at least 17 years of age. Exclusion Criteria: - Pregnant or breastfeeding - History of kidney stones or kidney disease - History of endocrine disorders - Allergies to any component of the food product bar |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Marine Corps Recruit Depot Parris Island | Parris Island | South Carolina |
Lead Sponsor | Collaborator |
---|---|
United States Army Research Institute of Environmental Medicine | Uniformed Services University of the Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum Bone Health Biomarkers (Composite) | Effect of calcium/vitamin D on the following serum biomarkers: 25(OH)D (ng/ml), parathyroid hormone (PTH) (pg/ml), C-telopeptide cross-links of type 1 collagen (CTX) (ng/ml), tartrate-resistant acid phosphatase (TRAP) (U/L), bone alkaline phosphatase (BAP) (ug/L), procollagen I N-terminal peptide (P1NP) (ug/L) |
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks | No |
Secondary | Bone Strength Indices (Composite) | Effect of calcium/vitamin D on the following indices of bone strength as assessed by peripheral quantitative computed tomography (pQCT): volumetric bone mineral density (vBMD) (mg/cm3), bone strength index (BSI) (mg/mm4), cortical bone mineral content (Crt BMC) (mg/mm), cortical volumetric bone mineral density (Crt vBMD) (mg/cm3), strength strain index (SSI) (no units) |
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02163668 -
Effects of Yoga on Bone Metabolism in Premenopausal Women
|
N/A | |
Completed |
NCT01058109 -
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls
|
Phase 3 | |
Active, not recruiting |
NCT05910606 -
Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.
|
N/A | |
Completed |
NCT05658159 -
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
|
||
Completed |
NCT03892395 -
An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health
|
N/A | |
Completed |
NCT02928913 -
The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health
|
N/A | |
Completed |
NCT01638182 -
Biocomparison Study
|
N/A | |
Recruiting |
NCT03455868 -
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
|
||
Completed |
NCT01617109 -
Optimizing Vitamin D Status During Initial Military Training
|
N/A | |
Completed |
NCT03956732 -
Effects of Milk Protein and Vitamin D on Children's Growth and Health
|
N/A | |
Enrolling by invitation |
NCT06351176 -
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
|
||
Completed |
NCT04064437 -
Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
|
||
Completed |
NCT01235325 -
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients
|
Phase 4 | |
Active, not recruiting |
NCT04573946 -
VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)
|
N/A | |
Recruiting |
NCT03533010 -
Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation
|
N/A | |
Completed |
NCT03651037 -
Physical Activity Platform to Improve Bone Health in Cancer Survivors
|
N/A | |
Not yet recruiting |
NCT03786835 -
Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health
|
N/A | |
Active, not recruiting |
NCT01747447 -
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)
|
N/A | |
Completed |
NCT03864172 -
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
|
N/A | |
Completed |
NCT04076618 -
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
|
N/A |