Study to Determine How Exercise and Calcium Affect Pubert... | NCT01087138

Studies
Study to Determine How Exercise and Calcium Affect Pubertal Bone

NCT01087138

Sponsor

Creighton University

Status

Completed

Last Update Posted

Mar 16, 2010Estimated

Enrollment

134Actual

Phase

Phase 3

Conditions

Bone Health

Interventions

exercise
exercise and calcium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Mar 12, 2010

First Submission Date that Met QC Criteria

Mar 15, 2010

First Posted Date

Mar 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2010

Last Update Posted Date

Mar 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	exercise class 3x's/week	Behavioral: exercise
exercise and calcium intake	Experimental	exercise class 3x's/week and 1500mg calcium/day	Behavioral: exercise and calcium
usual exercise and calcium	No Intervention	usual exercise and calcium intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Behavioral	exercise class 3x's/week	Exercise
exercise and calcium

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University		Omaha	Nebraska	68131	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D002118	Calcium

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided