Stress FractureNCT05186194
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
A study testing Vitamin D, Calcium in people with Stress Fracture and Vitamin d, run by Xijing Hospital at 1 site in China.
Trial summary
The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Stress Fracture, Vitamin d
- What is being tested?
- Vitamin D, Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to 30 Sep 2022
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recruits newly enlisted at a training base in September 2021.
- Agree to accept relevant inspections and serological research, and sign an informed consent form.
Who cannot join
- Suffer from diabetes, osteomyelitis and other diseases.
- Suffer from claustrophobia and other MRI examination contraindications.
- Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.
- A history of kidney disease.
- Allergic to any ingredient of the medicine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Orthopedics, Xijing Hospital, The Air Force Medical University
Xi’an, Shanxi, 710032
long bi, MD,PHD, +86 02984773524, bilong@fmmu.edu.cn
About this study
Official title: The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.
The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.
- Conditions
- Stress Fracture, Vitamin d
- Being tested
- Vitamin D, Calcium, Placebo
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D, CalciumDrug
Vitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Treatment) Group | Experimental | Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks. Receives: Drug: Vitamin D, Calcium |
| Control Group | Placebo comparator | Oral placebo, for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress fracture
Stress fractures were recorded when recruits reported to the clinic with suspected symptoms. All stress fractures were confirmed with radiography or Magnetic Resonance Imaging(MRI). Each subject with a stress fracture was recorded.
Measured: 3 months after the start of the basic military training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start30 Sep 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress FractureStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186194
- Sponsor's protocol ID
- KY20212116-F-2
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.
- ClinicalTrials.gov ID
- NCT05186194
- Acronym / sponsor ID
- KY20212116-F-2
- Conditions
- Stress Fracture, Vitamin d
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- 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 main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Treatment) Group | Experimental | Drug: Vitamin D, CalciumOral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks. |
| Control Group | Placebo comparator | Drug: PlaceboOral placebo, for 8 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Recruits newly enlisted at a training base in September 2021.
- Agree to accept relevant inspections and serological research, and sign an informed consent form.
Key exclusion criteria (5 listed)
- Suffer from diabetes, osteomyelitis and other diseases.
- Suffer from claustrophobia and other MRI examination contraindications.
- Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.
- A history of kidney disease.
- Allergic to any ingredient of the medicine.
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 |
|---|---|---|
| Vitamin D, CalciumVitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner. | Drug | Experimental (Treatment) Group |
| PlaceboPlacebo | Drug | Control Group |
Primary outcome
Stress fracture
Time frame: 3 months after the start of the basic military training.
Stress fractures were recorded when recruits reported to the clinic with suspected symptoms. All stress fractures were confirmed with radiography or Magnetic Resonance Imaging(MRI). Each subject with a stress fracture was recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Related trials for Stress Fracture
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
RecruitingObservational study
Bone Stress Injury Recovery and Return to Sport: A Natural History Study
Bone Stress Fracture
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D, Calcium in people with Stress Fracture and Vitamin d, run by Xijing Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact long bi, MD,PHD (+86 02984773524, bilong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress fracture (time frame: 3 months after the start of the basic military training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2022.