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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Vitamin d; Stress Fracture

Treatments: Drug: Vitamin D, Calcium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05186194

KY20212116-F-2

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups, including a placebo group

Experimental (Treatment) Group

Experimental group

Description:

Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.

Treatment:

Drug: Vitamin D, Calcium

Control Group

Placebo Comparator group

Description:

Oral placebo, for 8 weeks.

Treatment:

Drug: Placebo