Clinical trial NCT00063037: Building Better Bones in Children
Official title: Building Better Bones in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: Bone mass
Calcium intake
Prevention of osteoporosis
Optimizing peak bone mass
Bone mineral density
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2003-06-20
Enrollment: 139
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Babette Zemel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.