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

This study has been completed.
Sponsor:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT01058109
First received: January 27, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bone Health
 Other: calcium-rich diet
Other: Calcium rich diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Calcium Foods on Bone Quality in Pubertal Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: September 1997
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcium group
dietary calcium intake of 1500 mg/d
 Other: calcium-rich diet
dietary calcium intake of 1500 mg/d
Experimental: calcium-rich diet (1500 mg/d)
calcium intake from food
 Other: Calcium rich diet
dietary intake of 1500 mg/d from food

  Eligibility

Ages Eligible for Study:   9 Years to 9 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058109

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Joan M Lappe, PhD Creighton University
  More Information

No publications provided

Responsible Party: Joan M. Lappe, Creighton University
ClinicalTrials.gov Identifier: NCT01058109     History of Changes
Other Study ID Numbers: 97-11179
Study First Received: January 27, 2010
Last Updated: January 27, 2010
Health Authority: United States: National Institutes of Health

Keywords provided by Creighton University:
bone health, bone density, bone mass

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013