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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Fracture; Vitamin d
• Intervention / Treatment: Drug: Placebo; Drug: Vitamin D, Calcium

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: long bi, MD,PHD; Phone Number: +86 02984773524; Email: bilong@fmmu.edu.cn

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Department of Orthopedics, Xijing Hospital, The Air Force Medical University
      • Contact: long bi, MD,PHD; Phone Number: +86 02984773524; Email: bilong@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (Treatment) Group; Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.	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 Comparator: Control Group; Oral placebo, for 8 weeks.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: KY20212116-F-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No