Bone HealthNCT01617109
Optimizing Vitamin D Status During Initial Military Training
A study testing Ca/Vit D in people with Bone Health and Nutrition Status, run by United States Army Research Institute of Environmental Medicine at 2 sites in United States.
Trial summary
The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air… Read more about this study
- Who is it for?
- Ages 17 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Nutrition Status
- What is being tested?
- Ca/Vit D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to 2 May 2018
- 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 or US Air Force Recruits
- Participating in Basic Combat Training or Basic Military Training, respectively
Who cannot join
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fort Sill
Fort Sill, Oklahoma, 73503
Lackland Air Force Base
San Antonio, Texas, 78236
About this study
Official title: Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial
The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT).
The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.
Read the detailed description
Vitamin D is an essential nutrient for maintaining bone health. Previous work from our laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during the summer months in the Southeastern United States. Stress fractures may affect up to 5% of male and 21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin D and calcium supplementation may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin D and calcium requirements for military personnel during periods of elevated bone turnover.
- Conditions
- Bone Health, Nutrition Status
- Being tested
- Ca/Vit D, Placebo
- Keywords
- Vitamin D, Calcium, Parathyroid hormone, Bone, Bone formation, Bone resorption, Micronutrients, Trace Elements
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca/Vit DDietary supplement
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars
PlaceboOther
administered as 5 pills daily or as 2 snack bars
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Ca/Vit D | Experimental | Not described Receives: Dietary Supplement: Ca/Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PTH pg/ml
Measured: Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies 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
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James P McClung, Ph.D., Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617109
- Sponsor's protocol ID
- H12-09; 13-24HC
- Status last verified
- Oct 2018
- First submitted
- 1 Jun 2012
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Andersen NE, Karl JP, Cable SJ, Williams KW, Rood JC, Young AJ, Lieberman HR, McClung JP. Vitamin D status in female military personnel during combat training. J Int Soc Sports Nutr. 2010 Dec 14;7:38. doi: 10.1186/1550-2783-7-38.
PubMed 21156069Nakayama 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 30615068Lutz 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 29982620Gaffney-Stomberg E, Lutz LJ, Rood JC, Cable SJ, Pasiakos SM, Young AJ, McClung JP. Calcium and vitamin D supplementation maintains parathyroid hormone and improves bone density during initial military training: a randomized, double-blind, placebo controlled trial. Bone. 2014 Nov;68:46-56. doi: 10.1016/j.bone.2014.08.002. Epub 2014 Aug 10.
PubMed 25118085
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01617109
- Acronym / sponsor ID
- H12-09; 13-24HC
- Conditions
- Bone Health, Nutrition Status
- Keywords
- Vitamin D, Calcium, Parathyroid hormone, Bone, Bone formation, Bone resorption, Micronutrients, Trace Elements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 12 Jun 2012 (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 effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT).
The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.
Detailed description
Vitamin D is an essential nutrient for maintaining bone health. Previous work from our laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during the summer months in the Southeastern United States. Stress fractures may affect up to 5% of male and 21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin D and calcium supplementation may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin D and calcium requirements for military personnel during periods of elevated bone turnover.
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 |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Ca/Vit D | Experimental | Dietary Supplement: Ca/Vit D |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female or male US Army or US Air Force Recruits
- Participating in Basic Combat Training or Basic Military Training, respectively
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
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 |
|---|---|---|
| Ca/Vit D800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars | Dietary supplement | Ca/Vit D |
| Placeboadministered as 5 pills daily or as 2 snack bars | Other | Placebo |
Primary outcome
Serum PTH pg/ml
Time frame: Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 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 11 Oct 2018.
- Background: PubMed 21156069Andersen NE, Karl JP, Cable SJ, Williams KW, Rood JC, Young AJ, Lieberman HR, McClung JP. Vitamin D status in female military personnel during combat training. J Int Soc Sports Nutr. 2010 Dec 14;7:38. doi: 10.1186/1550-2783-7-38.
- 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.
- 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.
- Derived from this study: PubMed 25118085Gaffney-Stomberg E, Lutz LJ, Rood JC, Cable SJ, Pasiakos SM, Young AJ, McClung JP. Calcium and vitamin D supplementation maintains parathyroid hormone and improves bone density during initial military training: a randomized, double-blind, placebo controlled trial. Bone. 2014 Nov;68:46-56. doi: 10.1016/j.bone.2014.08.002. Epub 2014 Aug 10.
- 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.
James P McClung, Ph.D. principal investigator
US Army Research Institute of Environmental Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ca/Vit D in people with Bone Health and Nutrition Status, run by United States Army Research Institute of Environmental Medicine at 2 sites 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 2 inclusion and 2 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 PTH pg/ml (time frame: Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 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 NCT01617109, which also lists 4 linked publications.
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 11 Oct 2018.