NCT01087138

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

First QC Date

March 12, 2010

Last Update Submit

March 15, 2010

Conditions

Bone Health

Keywords

bone healthbone densitybone mass

Study Arms (3)

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

exerciseBEHAVIORAL

exercise class 3x's/week

Exercise
exercise and calciumBEHAVIORAL

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

exercise and calcium intake

Eligibility Criteria

Age9 Years - 9 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Premenarcheal
  • Female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Interventions

ExerciseCalcium

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 16, 2010

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

US(1)