Building Better Bones in Children
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral modification - nutrition education
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone mass, Calcium intake, Prevention of osteoporosis, Optimizing peak bone mass, Bone mineral density
Eligibility Criteria
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)
Sites / Locations
- The Children's Hospital of Philadelphia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00063037
First Posted
June 19, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00063037
Brief Title
Building Better Bones in Children
Official Title
Building Better Bones in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone mass, Calcium intake, Prevention of osteoporosis, Optimizing peak bone mass, Bone mineral density
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
139 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral modification - nutrition education
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babette Zemel, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28225052
Citation
Weber DR, Stark LJ, Ittenbach RF, Stallings VA, Zemel BS. Building better bones in childhood: a randomized controlled study to test the efficacy of a dietary intervention program to increase calcium intake. Eur J Clin Nutr. 2017 Jun;71(6):788-794. doi: 10.1038/ejcn.2017.5. Epub 2017 Feb 22.
Results Reference
derived
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Building Better Bones in Children
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