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

Phase 3

Completed

• Conditions: Bone Health
• Interventions: Other: calcium-rich diet; Other: Calcium rich diet

• Registration Number: NCT01058109
• Lead Sponsor: Creighton University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calcium group	calcium-rich diet	dietary calcium intake of 1500 mg/d
calcium-rich diet (1500 mg/d)	Calcium rich diet	calcium intake from food

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States