Nutrition StatusMCRD-PINCT02636348
Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training
A study testing Calcium/Vitamin D in people with Nutrition Status and Bone Health, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Status, Bone Health
- What is being tested?
- Calcium/Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female Marine Corps recruit at least 17 years of age.
Who cannot join
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of endocrine disorders
- Allergies to any component of the food product bar
Trial locations and contacts
1 site in 1 country.
United States1 site
Marine Corps Recruit Depot Parris Island
Parris Island, South Carolina, 29905
About this study
Official 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.
Read the detailed description
Military recruits undergoing initial military training (IMT) are 17 times more likely to develop stress fractures compared to active duty service members. Up to 800 male and female recruits will be enrolled at the MCRD, Parris Island, SC over two seasons (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) will be supplied as either capsules or a fortified food product daily throughout training. This study will provide novel data for the military, medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function, and the requirements for calcium and vitamin D to support bone health during IMT.
- Conditions
- Nutrition Status, Bone Health
- Being tested
- Calcium/Vitamin D, Placebo
- Keywords
- Calcium, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium/Vitamin DDietary supplement
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
PlaceboDietary supplement
Administered daily as 8 placebo pills or 2 unfortified snack bars.
| Study group | Role | What they receive |
|---|---|---|
| Calcium/Vitamin D Bar | Experimental | Dietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day Receives: Dietary Supplement: Calcium/Vitamin D |
| Calcium/Vitamin D Pill | Experimental | Dietary supplement consumed as several capsules per day Receives: Dietary Supplement: Calcium/Vitamin D |
| Placebo Bar | Placebo comparator | Placebo consumed as 2 isocaloric, unfortified snack bars per day Receives: Dietary Supplement: Placebo |
| Placebo Pill | Placebo comparator | Placebo consumed as several capsules per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Secondary outcomes (1)
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)
Measured: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Erin Gaffney-Stomberg, Ph.D., R.D., Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636348
- Sponsor's protocol ID
- 15-21-HC
- Acronym
- MCRD-PI
- Status last verified
- Oct 2016
- First submitted
- 24 Jun 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nakayama AT, Lutz LJ, Hruby A, Karl JP, McClung JP, Gaffney-Stomberg E. A dietary pattern rich in calcium, potassium, and protein is associated with tibia bone mineral content and strength in young adults entering initial military training. Am J Clin Nutr. 2019 Jan 1;109(1):186-196. doi: 10.1093/ajcn/nqy199.
PubMed 30615068
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
- ClinicalTrials.gov ID
- NCT02636348
- Acronym / sponsor ID
- MCRD-PI / 15-21-HC
- Conditions
- Nutrition Status, Bone Health
- Keywords
- Calcium, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Military recruits undergoing initial military training (IMT) are 17 times more likely to develop stress fractures compared to active duty service members. Up to 800 male and female recruits will be enrolled at the MCRD, Parris Island, SC over two seasons (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) will be supplied as either capsules or a fortified food product daily throughout training. This study will provide novel data for the military, medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function, and the requirements for calcium and vitamin D to support bone health during IMT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calcium/Vitamin D Bar | Experimental | Dietary Supplement: Calcium/Vitamin DDietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day |
| Calcium/Vitamin D Pill | Experimental | Dietary Supplement: Calcium/Vitamin DDietary supplement consumed as several capsules per day |
| Placebo Bar | Placebo comparator | Dietary Supplement: PlaceboPlacebo consumed as 2 isocaloric, unfortified snack bars per day |
| Placebo Pill | Placebo comparator | Dietary Supplement: PlaceboPlacebo consumed as several capsules per day |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female Marine Corps recruit at least 17 years of age.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of endocrine disorders
- Allergies to any component of the food product bar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium/Vitamin D2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars. | Dietary supplement | Calcium/Vitamin D Bar, Calcium/Vitamin D Pill |
| PlaceboAdministered daily as 8 placebo pills or 2 unfortified snack bars. | Dietary supplement | Placebo Bar, Placebo Pill |
Primary outcome
Serum Bone Health Biomarkers (Composite)
Time frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
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)
1 secondary outcome
Bone Strength Indices (Composite)
Time frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 30615068Nakayama AT, Lutz LJ, Hruby A, Karl JP, McClung JP, Gaffney-Stomberg E. A dietary pattern rich in calcium, potassium, and protein is associated with tibia bone mineral content and strength in young adults entering initial military training. Am J Clin Nutr. 2019 Jan 1;109(1):186-196. doi: 10.1093/ajcn/nqy199.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Gaffney-Stomberg, Ph.D., R.D. principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium/Vitamin D in people with Nutrition Status and Bone Health, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Bone Health Biomarkers (Composite) (time frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.