Study to Determine How Exercise and Calcium Affect Pubertal Bone

Phase 3

Completed

• Conditions: Bone Health
• Interventions: Behavioral: exercise and calcium; Behavioral: exercise

• Registration Number: NCT01087138
• Lead Sponsor: Creighton University

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 available

Study Timeline

• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-15
• Last Update Submitted: 2010-03-15
• Study First Posted: 2010-03-16
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise and calcium intake	exercise and calcium	exercise class 3x's/week and 1500mg calcium/day
Exercise	exercise	exercise class 3x's/week

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States