Back to resultsThe Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
Primary Purpose
Stress Fracture, Vitamin d
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitamin D, Calcium
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Stress Fracture
Eligibility Criteria
Inclusion Criteria:
- Recruits newly enlisted at a training base in September 2021.
- Agree to accept relevant inspections and serological research, and sign an informed consent form.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Orthopedics, Xijing Hospital, The Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental (Treatment) Group
Control Group
Arm Description
Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.
Oral placebo, for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05186194
Brief Title
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
Official Title
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Fracture, Vitamin d
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental (Treatment) Group
Arm Type
Experimental
Arm Description
Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Oral placebo, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin D, Calcium
Intervention Description
Vitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Stress fracture
Description
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.
Time Frame
3 months after the start of the basic military training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recruits newly enlisted at a training base in September 2021.
Agree to accept relevant inspections and serological research, and sign an informed consent form.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
long bi, MD,PHD
Phone
+86 02984773524
Email
bilong@fmmu.edu.cn
Facility Information:
Facility Name
Department of Orthopedics, Xijing Hospital, The Air Force Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
long bi, MD,PHD
Phone
+86 02984773524
Email
bilong@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
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