Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063037
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-06-19
Brief Title:
Building Better Bones in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Building Better Bones in Children
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 childrens 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
Participants will be recruited into two groups a group of healthy children with no known risk factors for low bone density ie 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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None