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

NCT ID: NCT05186194

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Stress Fracture Vitamin d

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental (Treatment) Group

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

Group Type EXPERIMENTAL

Vitamin D, Calcium

Intervention Type DRUG

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

Control Group

Oral placebo, for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Orthopedics, Xijing Hospital, The Air Force Medical University

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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long bi, MD,PHD

Role: CONTACT

+86 02984773524

Facility Contacts

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long bi, MD,PHD

Role: primary

+86 02984773524

Other Identifiers

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KY20212116-F-2

Identifier Type: -

Identifier Source: org_study_id

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