NCT01058109

Brief Summary

The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 1997

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

11.3 years

First QC Date

January 27, 2010

Last Update Submit

March 24, 2016

Conditions

Bone Health

Keywords

bone health, bone density, bone mass

Outcome Measures

Primary Outcomes (1)

  • The specific aim of this project was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in pubertal females beginning at age nine.

    9 years

Study Arms (2)

calcium group

EXPERIMENTAL

dietary calcium intake of 1500 mg/d

Other: calcium-rich diet

calcium-rich diet (1500 mg/d)

EXPERIMENTAL

calcium intake from food

Other: Calcium rich diet

Interventions

calcium-rich dietOTHER

dietary calcium intake of 1500 mg/d

calcium group
Calcium rich dietOTHER

dietary intake of 1500 mg/d from food

calcium-rich diet (1500 mg/d)

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Study Officials

  • Joan M Lappe, PhD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

September 1, 1997

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 28, 2016

Record last verified: 2016-03

Locations

US(1)