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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:
ClinicalTrials.gov Identifier:
NCT01058109
First Posted: January 28, 2010
Last Update Posted: March 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joan Lappe, Creighton University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Calcium Foods on Bone Quality in Pubertal Females

Resource links provided by NLM:


Further study details as provided by Joan Lappe, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 9 Years   (Child)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joan Lappe, Professor of Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT01058109     History of Changes
Other Study ID Numbers: 97-11179
First Submitted: January 27, 2010
First Posted: January 28, 2010
Last Update Posted: March 28, 2016
Last Verified: March 2016

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

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