Full Text View
Tabular View
No Study Results Posted
Related Studies
Building Better Bones in Children
This study is ongoing, but not recruiting participants.
Study NCT00063037   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: June 19, 2003   Last Updated: June 23, 2005   History of Changes

June 19, 2003
June 23, 2005
June 1999
 
 
 
Complete list of historical versions of study NCT00063037 on ClinicalTrials.gov Archive Site
 
 
 
Building Better Bones in Children
Building Better Bones in Children

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.

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.

 
Interventional
Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Osteoporosis
Behavioral: Behavioral modification - nutrition education
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
139
May 2005
 

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)
Both
7 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063037
 
R01HD37748
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2003

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