OsteoporosisNCT00063037
Building Better Bones in Children
A study testing Behavioral modification - nutrition education in people with Osteoporosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Behavioral modification - nutrition education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Height or weight above the third percentile for age
- Normal weight (< 130% of desirable body weight)
- English speaking
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
About this study
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Behavioral modification - nutrition education
- Keywords
- Bone mass, Calcium intake, Prevention of osteoporosis, Optimizing peak bone mass, Bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral modification - nutrition educationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study startJun 1999
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 139 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Babette Zemel, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063037
- Sponsor's protocol ID
- R01HD037748
- Status last verified
- May 2003
- First submitted
- 19 Jun 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 28225052
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Better Bones in Children
- ClinicalTrials.gov ID
- NCT00063037
- Acronym / sponsor ID
- R01HD037748
- Conditions
- Osteoporosis
- Keywords
- Bone mass, Calcium intake, Prevention of osteoporosis, Optimizing peak bone mass, Bone mineral density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jun 1999
- Study completion
- May 2005
- First posted
- 20 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Height or weight above the third percentile for age
- Normal weight (< 130% of desirable body weight)
- English speaking
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral modification - nutrition education | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 28225052Weber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babette Zemel, Ph.D. principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral modification - nutrition education in people with Osteoporosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00063037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.