Study of the Effect of a Calcium-rich Diet on Bone Health in Girls

NCT ID: NCT01058109

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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calcium group

dietary calcium intake of 1500 mg/d

Group Type EXPERIMENTAL

calcium-rich diet

Intervention Type OTHER

dietary calcium intake of 1500 mg/d

calcium-rich diet (1500 mg/d)

calcium intake from food

Group Type EXPERIMENTAL

Calcium rich diet

Intervention Type OTHER

dietary intake of 1500 mg/d from food

Interventions

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calcium-rich diet

dietary calcium intake of 1500 mg/d

Intervention Type OTHER

Calcium rich diet

dietary intake of 1500 mg/d from food

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

\- Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.

Exclusion Criteria:

* Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.
Minimum Eligible Age

9 Years

Maximum Eligible Age

9 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Joan Lappe

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan M Lappe, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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97-11179

Identifier Type: -

Identifier Source: org_study_id

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