The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
1 other identifier
interventional
240
1 country
1
Brief 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. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJanuary 11, 2022
December 1, 2021
9 months
December 8, 2021
December 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months after the start of the basic military training.
Study Arms (2)
Experimental (Treatment) Group
EXPERIMENTALOral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.
Control Group
PLACEBO COMPARATOROral placebo, for 8 weeks.
Interventions
Vitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner.
Eligibility Criteria
You may qualify if:
- Recruits newly enlisted at a training base in September 2021.
- Agree to accept relevant inspections and serological research, and sign an informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Department of Orthopedics, Xijing Hospital, The Air Force Medical University
Xi’an, Shanxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
January 11, 2022
Study Start
September 30, 2021
Primary Completion
June 30, 2022
Study Completion
September 30, 2022
Last Updated
January 11, 2022
Record last verified: 2021-12