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Building Better Bones in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
National Center for Research Resources (NCRR)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: June 19, 2003
Last updated: June 23, 2005
Last verified: May 2003
Calcium is important for healthy bone growth in children. Poor bone growth and development during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition education program designed to increase the amount of calcium children receive. The study will determine whether the program will result in long-term dietary changes and healthier bones in children.

Condition Intervention
Behavioral: Behavioral modification - nutrition education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Building Better Bones in Children

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 139
Study Start Date: June 1999
Estimated Study Completion Date: May 2005
Detailed Description:

Increased calcium intake is effective in increasing bone mineral density in children, but the effect disappears when calcium supplements are discontinued. Increased dietary calcium from daily food sources may have a greater impact on bone density than that achieved by calcium supplements. However, studies have not yet demonstrated sustained achievement of increased calcium from food sources. In addition, the effects of baseline calcium intake, bone density, and puberty status may influence bone response to increased dietary calcium. This study will develop, implement, and evaluate a Behavioral Modification-Nutrition Education (BM-NE) Intervention Program designed to promote sustained increases in dietary calcium. The study will quantify the impact of increased dietary calcium on bone density during growth and development and will determine whether the presence of risk factors for low bone density influences compliance with the program.

Participants will be recruited into two groups: a group of healthy children with no known risk factors for low bone density (i.e., no known chronic disease or previous oral steroid exposure), and a group of healthy children with potential risk factors for low bone density (previous fracture from usual childhood activities, daily dietary calcium refusal, lactose intolerance, family history of osteoporosis). Children with and without risk factors will be randomly assigned to participate in an intensive BM-NE intervention group or a usual care group that will receive counseling on bone health. The BM-NE Program will consist of five group sessions for parents and children over 6 weeks. The program will use individualized plans to increase children's calcium intake to 1500 mg per day.

Children will be followed for 3 years. Primary outcome measures will include daily calcium intake and bone mineral density. Data on height, weight, sexual and skeletal maturation, and physical activity will also be collected.


Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Height or weight above the third percentile for age
  • Normal weight (< 130% of desirable body weight)
  • English speaking

Exclusion Criteria

  • Significant health condition
  • Medication known to affect growth (e.g., thyroxin, growth hormone, steroid medication)
  • Ritalin or Adderall medication
  • Significant developmental or delay impairment (e.g., autism, cerebral palsy, mental retardation)
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Please refer to this study by its identifier: NCT00063037

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Principal Investigator: Babette Zemel, Ph.D. Children's Hospital of Philadelphia
  More Information Identifier: NCT00063037     History of Changes
Other Study ID Numbers: R01HD037748 ( US NIH Grant/Contract Award Number )
Study First Received: June 19, 2003
Last Updated: June 23, 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Bone mass
Calcium intake
Prevention of osteoporosis
Optimizing peak bone mass
Bone mineral density

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on May 23, 2017