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

Vitamin d Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186194
• Other study ID #: KY20212116-F-2
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2021
• Source: Xijing Hospital
• Contact: long bi, MD,PHD
• Phone: +86 02984773524
• Email: bilong[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Stress Fracture
• Vitamin d

Intervention

Drug:
• Vitamin D, Calcium
Vitamin D, calcium are available in tablets. During the 8 weeks of training, subjects were asked to take supplement tablets per day after dinner.
• Placebo
Placebo

Locations

Country	Name	City	State
China	Department of Orthopedics, Xijing Hospital, The Air Force Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.