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OpenTrials
Completed

NCT Number: NCT01058109

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

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.

Completed

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Key information

Conditions

Age range

9 year–9 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Creighton University

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcium-rich diet

Other

dietary calcium intake of 1500 mg/d

Calcium rich diet

Other

dietary intake of 1500 mg/d from food

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.

    Time frame: 9 years

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

Effect of Calcium Foods on Bone Quality in Pubertal Females

Acronym: Calkids

Important dates

Study start
1997
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2010
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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