HealthyNCT01897168
Bone Mineral Content in Healthy Children
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the effects of early diet on bone health. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children
Who may be able to join
- Current or past participation in the Beginnings study (IRB#07180)
- Age 5-7 years
Who cannot join
- Growth or bone disorders
- Non-removal metal on participant
- Any other conditions that may affect the outcome of interest as determined by the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
The primary purpose of this study is to determine the effects of early diet on bone health.
- Conditions
- Healthy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| No grouping | Not described Receives: Device: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone health assessed by pQCT and DXA
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Ran Chen, Ph.D., Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897168
- Sponsor's protocol ID
- 135180
- Status last verified
- Jan 2025
- First submitted
- 27 Mar 2013
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Content in Healthy Children
- ClinicalTrials.gov ID
- NCT01897168
- Acronym / sponsor ID
- 135180
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Jul 2013 (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.
The primary purpose of this study is to determine the effects of early diet on bone health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No grouping | – | Device: No intervention |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children
Key inclusion criteria (2 listed)
- Current or past participation in the Beginnings study (IRB#07180)
- Age 5-7 years
Key exclusion criteria (3 listed)
- Growth or bone disorders
- Non-removal metal on participant
- Any other conditions that may affect the outcome of interest as determined by the PI.
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 |
|---|---|---|
| No intervention | Device | No grouping |
Primary outcome
Bone health assessed by pQCT and DXA
Time frame: 5-7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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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.
Jin-Ran Chen, Ph.D. principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute 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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Bone health assessed by pQCT and DXA (time frame: 5-7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.