Building Better Bones in Children

Osteoporosis Clinical Trial

Official title:

Building Better Bones in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00063037
• Other study ID #: R01HD037748
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2003
• Last updated: June 23, 2005
• Start date: June 1999
• Est. completion date: May 2005

Study information

• Verified date: May 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Behavioral modification - nutrition education

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,