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

Bone Health Clinical Trial

— Calkids  

Official title:

Effect of Calcium Foods on Bone Quality in Pubertal Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058109
• Other study ID #: 97-11179
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2010
• Last updated: March 24, 2016
• Start date: September 1997
• Est. completion date: December 2008

Study information

• Verified date: March 2016
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institutes of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Health

Intervention

Other:
• calcium-rich diet
dietary calcium intake of 1500 mg/d
• Calcium rich diet
dietary intake of 1500 mg/d from food

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No