Study to Determine How Exercise and Calcium Affect Pubertal Bone

NCT ID: NCT01087138

Last Updated: 2010-03-16

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise

exercise class 3x's/week

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

exercise class 3x's/week

exercise and calcium intake

exercise class 3x's/week and 1500mg calcium/day

Group Type EXPERIMENTAL

exercise and calcium

Intervention Type BEHAVIORAL

exercise class 3x's/week and 1500mg calcium intake

usual exercise and calcium

usual exercise and calcium intake

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

exercise class 3x's/week

Intervention Type BEHAVIORAL

exercise and calcium

exercise class 3x's/week and 1500mg calcium intake

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

9 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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97-11384

Identifier Type: -

Identifier Source: org_study_id

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