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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087138
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Creighton University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone Health Behavioral: exercise Behavioral: exercise and calcium Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Exercise and Calcium Foods on Pubertal Bone Gain
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Arms and Interventions
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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


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   9 Years to 9 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087138


Locations
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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
More Information
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Responsible Party: Joan M. Lappe, Creighton University
ClinicalTrials.gov Identifier: NCT01087138    
Other Study ID Numbers: 97-11384
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Creighton University:
bone health
bone density
bone mass
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs