Physical ActivityPhase 2NCT00000415
Physical Activity, Calcium, and Bone in Children
A Phase 2 study testing Physical activity and Calcium supplement in people with Physical Activity and Nutrition, run by South Dakota State University at 1 site in United States.
Trial summary
Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Nutrition
- What is being tested?
- Physical activity and Calcium supplement
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Mar 2003
- Phase
- Phase 2
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in participating childcare center.
- Does not plan to attend kindergarten or withdraw from center in the next 12 months.
Who cannot join
- Chronic disease that may interfere with growth and bone mass accretion (cystic fibrosis, liver disease, asthma that is being treated with steroids, juvenile rheumatoid arthritis, immobilization).
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University
Brookings, South Dakota, 57007
About this study
Official title: Calcium Modifies Bone Response to Activity in Children
Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. The goal of this study is to find out whether calcium intake changes the response of bone to activity in children 3 to 4 years old. Children will participate in one of two programs conducted in childcare centers 5 days a week for 1 year. One program will involve activities that use large muscles (gross motor activity). The other will involve activities using small muscles (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the children in each program and give the other half an inactive pill. We will measure bone mass and bone mineral density at the beginning and end of the study. We will take measurements 12 months after the program's completion to see if physical activity and/or calcium supplements have long-term effects on bone mineral density and physical activity.
Read the detailed description
Participation in daily physical activity programs by young children is currently recommended as a means of promoting bone health. Results from studies of adults indicate that beneficial effects of either physical activity or calcium (Ca) intake may be apparent only when both these factors are present. Our results in infants indicate that physical activity combined with a low Ca diet may be detrimental in terms of bone mass accretion. The overall objective of this study is to determine whether Ca intake modifies the bone response to activity in young children 3 to 4 years of age.
Our hypotheses are that (1) the increase in bone mass resulting from a physical activity program will be more pronounced in children randomized to receive a Ca supplement compared to the increase in children randomized to receive a placebo; and (2) 12 months after cessation of the activity program, bone mass will remain higher in children randomized to gross motor activity compared to children randomized to fine motor activity, and the beneficial effect of Ca supplementation will persist only among children randomized to gross motor activity. We will test these hypotheses in a randomized 2 x 2 factorial trial in 3- to 4-year-old children. We will randomize children into either a gross motor or fine motor activity program that will be conducted in childcare centers 5 days a week for 1 year. We will further randomize each child into either a Ca supplement (1 g/d) or placebo group.
The primary outcomes of the study are bone mass accretion and changes in bone mineral density, which we will determine by dual energy x-ray absorptiometry at the beginning and end of the study. We will do activity assessments throughout the study period to determine whether participation in the gross motor activity group also increases spontaneous activity in these children. Anthropometric measurements and dietary information will allow us to statistically control for these potential confounders. We will obtain additional bone mass and physical activity measurements 12 months after completion of the program to determine if these interventions have long-term effects on bone mineral density and physical activity.
A finding of beneficial effects of Ca supplementation or physical activity, either independent of each other or in combination, will lay the groundwork for devising prevention strategies within the educational system that optimize bone health beginning early in life. However, we may find that increased physical activity in the presence of a low to moderate Ca intake may have a detrimental effect on bone mass accretion during periods of rapid growth.
- Conditions
- Physical Activity, Nutrition
- Being tested
- Physical activity, Calcium supplement
- Keywords
- Calcium, Physical activity, Children, Bone mass accretion, Bone mineral density (BMD), Bone response to activity and calcium supplements, Placebo, Bone growth
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityProcedure or surgery
Calcium supplementDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startApr 1998
- Primary completionFeb 2003
- Study completionMar 2003
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 Physical ActivityStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 224 participants
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Bonny Specker, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000415
- Sponsor's protocol ID
- R01AR045310
- Other IDs
- R01AR045310, NIAMS-010
- Status last verified
- Jun 2013
- First submitted
- 3 Nov 1999
- Last updated
- 4 Jun 2013
- Results posted
- No
Publications
Specker B, Binkley T. Randomized trial of physical activity and calcium supplementation on bone mineral content in 3- to 5-year-old children. J Bone Miner Res. 2003 May;18(5):885-92. doi: 10.1359/jbmr.2003.18.5.885.
PubMed 12733728
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Modifies Bone Response to Activity in Children
- ClinicalTrials.gov ID
- NCT00000415
- Acronym / sponsor ID
- R01AR045310
- Conditions
- Physical Activity, Nutrition
- Keywords
- Calcium, Physical activity, Children, Bone mass accretion, Bone mineral density (BMD), Bone response to activity and calcium supplements, Placebo, Bone growth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 1998
- Primary completion
- Feb 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 4 Nov 1999 (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.
Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. The goal of this study is to find out whether calcium intake changes the response of bone to activity in children 3 to 4 years old. Children will participate in one of two programs conducted in childcare centers 5 days a week for 1 year. One program will involve activities that use large muscles (gross motor activity). The other will involve activities using small muscles (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the children in each program and give the other half an inactive pill. We will measure bone mass and bone mineral density at the beginning and end of the study. We will take measurements 12 months after the program's completion to see if physical activity and/or calcium supplements have long-term effects on bone mineral density and physical activity.
Detailed description
Participation in daily physical activity programs by young children is currently recommended as a means of promoting bone health. Results from studies of adults indicate that beneficial effects of either physical activity or calcium (Ca) intake may be apparent only when both these factors are present. Our results in infants indicate that physical activity combined with a low Ca diet may be detrimental in terms of bone mass accretion. The overall objective of this study is to determine whether Ca intake modifies the bone response to activity in young children 3 to 4 years of age.
Our hypotheses are that (1) the increase in bone mass resulting from a physical activity program will be more pronounced in children randomized to receive a Ca supplement compared to the increase in children randomized to receive a placebo; and (2) 12 months after cessation of the activity program, bone mass will remain higher in children randomized to gross motor activity compared to children randomized to fine motor activity, and the beneficial effect of Ca supplementation will persist only among children randomized to gross motor activity. We will test these hypotheses in a randomized 2 x 2 factorial trial in 3- to 4-year-old children. We will randomize children into either a gross motor or fine motor activity program that will be conducted in childcare centers 5 days a week for 1 year. We will further randomize each child into either a Ca supplement (1 g/d) or placebo group.
The primary outcomes of the study are bone mass accretion and changes in bone mineral density, which we will determine by dual energy x-ray absorptiometry at the beginning and end of the study. We will do activity assessments throughout the study period to determine whether participation in the gross motor activity group also increases spontaneous activity in these children. Anthropometric measurements and dietary information will allow us to statistically control for these potential confounders. We will obtain additional bone mass and physical activity measurements 12 months after completion of the program to determine if these interventions have long-term effects on bone mineral density and physical activity.
A finding of beneficial effects of Ca supplementation or physical activity, either independent of each other or in combination, will lay the groundwork for devising prevention strategies within the educational system that optimize bone health beginning early in life. However, we may find that increased physical activity in the presence of a low to moderate Ca intake may have a detrimental effect on bone mass accretion during periods of rapid growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in participating childcare center.
- Does not plan to attend kindergarten or withdraw from center in the next 12 months.
Key exclusion criteria (1 listed)
- Chronic disease that may interfere with growth and bone mass accretion (cystic fibrosis, liver disease, asthma that is being treated with steroids, juvenile rheumatoid arthritis, immobilization).
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 |
|---|---|---|
| Physical activity | Procedure or surgery | – |
| Calcium supplement | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Background: PubMed 12733728Specker B, Binkley T. Randomized trial of physical activity and calcium supplementation on bone mineral content in 3- to 5-year-old children. J Bone Miner Res. 2003 May;18(5):885-92. doi: 10.1359/jbmr.2003.18.5.885.
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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.
Bonny Specker, PhD principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical activity and Calcium supplement in people with Physical Activity and Nutrition, run by South Dakota State University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jun 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00000415, 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 4 Jun 2013.