Study to Determine How Exercise and Calcium Affect Pubertal Bone (Exkids)

March 15, 2010 updated by: Creighton University

Effect of Exercise and Calcium Foods on Pubertal Bone Gain

To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 9-10 years of age
  • Premenarcheal
  • Female

Exclusion Criteria:

  • corticosteroid or anticonvulsant therapy
  • lactose intolerance or milk allergy
  • family history of hypercholesterolemia
  • mental or physical handicaps
  • chronic disease
  • body mass index ³ 85th percentile for age and gender
  • baseline calcium intake of > 1100 mg/day
  • participation in team sports > 3 times per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise
exercise class 3x's/week
Behavioral: exercise
exercise class 3x's/week
EXPERIMENTAL: exercise and calcium intake
exercise class 3x's/week and 1500mg calcium/day
Behavioral: exercise and calcium
exercise class 3x's/week and 1500mg calcium intake
NO_INTERVENTION: usual exercise and calcium
usual exercise and calcium intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (ESTIMATE)

March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-11384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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