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NCT01087138 Clinical Trial

Study to Determine How Exercise and Calcium Affect Pubertal Bone

Bone Health Clinical Trial

— Exkids  

Official title:
Effect of Exercise and Calcium Foods on Pubertal Bone Gain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01087138
Other study ID # 97-11384
Secondary ID
Status Completed
Phase Phase 3
First received March 12, 2010
Last updated March 15, 2010
Est. completion date April 2007

Study information
Verified date March 2010
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 9 Years to 9 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Creighton University Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

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