The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.

Not Applicable

• Conditions: Stress Fracture; Vitamin d
• Interventions: Drug: Vitamin D, Calcium; Drug: Placebo

• Registration Number: NCT05186194
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-22
• Last Update Submitted: 2021-12-22
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental (Treatment) Group	Vitamin D, Calcium	Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.
Control Group	Placebo	Oral placebo, for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Stress fracture	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.

Trial Locations

Locations (1)

Department of Orthopedics, Xijing Hospital, The Air Force Medical University; 🇨🇳 Xi'an, Shanxi, China