Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 27, 2010
January 27, 2010
September 1997
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls
Effect of Calcium Foods on Bone Quality in Pubertal Females

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Bone Health
  • Other: calcium-rich diet
    dietary calcium intake of 1500 mg/d
  • Other: Calcium rich diet
    dietary intake of 1500 mg/d from food
  • Experimental: calcium group
    dietary calcium intake of 1500 mg/d
    Intervention: Other: calcium-rich diet
  • Experimental: calcium-rich diet (1500 mg/d)
    calcium intake from food
    Intervention: Other: Calcium rich diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Female
9 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058109
97-11179
No
Joan M. Lappe, Creighton University
Creighton University
Not Provided
Principal Investigator: Joan M Lappe, PhD Creighton University
Creighton University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP