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

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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