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

Creighton University

Status and phase: Completed; Phase 3

Conditions: Bone Health

Treatments: Behavioral: exercise and calcium; Behavioral: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01087138

97-11384

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: Female

Ages: 9 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 3 patient groups

Exercise

Experimental group

Description:

exercise class 3x's/week

Treatment:

Behavioral: exercise

exercise and calcium intake

Experimental group

Description:

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

Treatment:

Behavioral: exercise and calcium

usual exercise and calcium

No Intervention group

Description:

usual exercise and calcium intake