Bone AlterationNCT02375503
Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture
A study testing Calcium/Vitamin D in people with Bone Alteration and Dietary Modification, 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 of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). Read more about this study
- Who is it for?
- Ages 17 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Alteration, Dietary Modification
- What is being tested?
- Calcium/Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2015
- 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 to 42 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina
Who cannot join
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of amenorrhea
- History or endocrine disorders
- History of bone modifying disorders
- Currently taking, or have taken glucocorticoid drugs in the 2 years prior to study participation
- Currently diagnosed as anemic by healthcare professional
- Those allergic to any component of the snack bar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture in Response to Army Basic Combat Training
The primary objective of this randomized, double-blind, placebo controlled trial is to determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). The investigators hypothesize that consumption of a once daily calcium and vitamin D fortified food product will stabilize PTH and contribute to improved bone microarchitecture compared to placebo. The results will determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover markers as well as provide novel data regarding microarchitectural changes during BCT as assessed by high resolution peripheral computed tomography (HRpQCT) scanning.
Read the detailed description
Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel. A recent report indicates that supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has been measured in response to basic training however, the resolution of standard peripheral quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT this study will allow the investigators to evaluate microarchitectural changes within the bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to support bone health during BCT.
- Conditions
- Bone Alteration, Dietary Modification
- Being tested
- Calcium/Vitamin D, Placebo
- Keywords
- Calcium, Vitamin D, Parathyroid Hormone, Bone, Microarchitecture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium/Vitamin DDietary supplement
Daily, calcium and vitamin D fortified snack bar
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Calcium/Vitamin D | Experimental | Dietary supplement distributed and consumed as one calcium and vitamin D fortified snack bar per day Receives: Dietary Supplement: Calcium/Vitamin D |
| Placebo | Placebo comparator | Placebo distributed and consumed as one isocaloric, unfortified snack bar per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Turnover Markers
Participants will have a pre- and post- BCT blood draw
Measured: 8-10 weeks
Secondary outcomes (1)
Bone Microarchitecture
Participants will receive a bone scan pre- and post- BCT in order to determine changes in bone microarchitecture
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
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 Bone AlterationStudies 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Erin Gaffney-Stomberg, Ph.D., R.D., Principal investigator, U.S. Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375503
- Sponsor's protocol ID
- 15-07-HC
- Status last verified
- May 2017
- First submitted
- 24 Feb 2015
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lutz LJ, Gaffney-Stomberg E, Karl JP, Hughes JM, Guerriere KI, McClung JP. Dietary Intake in Relation to Military Dietary Reference Values During Army Basic Combat Training; a Multi-center, Cross-sectional Study. Mil Med. 2019 Mar 1;184(3-4):e223-e230. doi: 10.1093/milmed/usy153.
PubMed 29982620
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture in Response to Army Basic Combat Training
- ClinicalTrials.gov ID
- NCT02375503
- Acronym / sponsor ID
- 15-07-HC
- Conditions
- Bone Alteration, Dietary Modification
- Keywords
- Calcium, Vitamin D, Parathyroid Hormone, Bone, Microarchitecture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Mar 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 of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). The investigators hypothesize that consumption of a once daily calcium and vitamin D fortified food product will stabilize PTH and contribute to improved bone microarchitecture compared to placebo. The results will determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover markers as well as provide novel data regarding microarchitectural changes during BCT as assessed by high resolution peripheral computed tomography (HRpQCT) scanning.
Detailed description
Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel. A recent report indicates that supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has been measured in response to basic training however, the resolution of standard peripheral quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT this study will allow the investigators to evaluate microarchitectural changes within the bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to support bone health during BCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium/Vitamin D | Experimental | Dietary Supplement: Calcium/Vitamin DDietary supplement distributed and consumed as one calcium and vitamin D fortified snack bar per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo distributed and consumed as one isocaloric, unfortified snack bar per day |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of amenorrhea
- History or endocrine disorders
- History of bone modifying disorders
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 DDaily, calcium and vitamin D fortified snack bar | Dietary supplement | Calcium/Vitamin D |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Bone Turnover Markers
Time frame: 8-10 weeks
Participants will have a pre- and post- BCT blood draw
1 secondary outcome
Bone Microarchitecture
Time frame: 8-10 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 15 May 2017.
- Derived from this study: PubMed 29982620Lutz LJ, Gaffney-Stomberg E, Karl JP, Hughes JM, Guerriere KI, McClung JP. Dietary Intake in Relation to Military Dietary Reference Values During Army Basic Combat Training; a Multi-center, Cross-sectional Study. Mil Med. 2019 Mar 1;184(3-4):e223-e230. doi: 10.1093/milmed/usy153.
- Individual participant dataSharing planned: Undecided
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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
U.S. 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 Bone Alteration and Dietary Modification, 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 8 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 15 May 2017. 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?
Bone Turnover Markers (time frame: 8-10 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 NCT02375503, 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 15 May 2017.