HealthyNCT00730587
Study of Body Composition Methodology in Young Children (InfantPod)
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years. Read more about this study
- Who is it for?
- Ages 5 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 5 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children in the greater Little Rock area.
Who may be able to join
- Healthy children between ages of 5 months and 3 years
Who cannot join
- Child that has any condition that may affect growth
- Child that has any chronic disease
- Child that has any carbohydrate metabolism disorder
- Child that takes any medications that may interfere with study parameters as determined by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Development of a Body Composition Method for Infants and Children
The InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years.
- Conditions
- Healthy
- Keywords
- Nutrition, Body Fat, Infant, Healthy Babies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Full-term healthy infants ages 5 months to 3 years. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
Why it stopped: This study will not be conducted. A new study is replacing this one.
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), University of Arkansas
- Investigators
- Aline Andres, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730587
- Sponsor's protocol ID
- 105169
- Status last verified
- Jan 2016
- First submitted
- 6 Aug 2008
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Body Composition Method for Infants and Children
- ClinicalTrials.gov ID
- NCT00730587
- Acronym / sponsor ID
- 105169
- Conditions
- Healthy
- Keywords
- Nutrition, Body Fat, Infant, Healthy Babies
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study will not be conducted. A new study is replacing this one.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), University of Arkansas
- First posted
- 8 Aug 2008 (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 InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Full-term healthy infants ages 5 months to 3 years. |
Who may qualify
- Ages
- 5 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children in the greater Little Rock area.
Key inclusion criteria (1 listed)
- Healthy children between ages of 5 months and 3 years
Key exclusion criteria (4 listed)
- Child that has any condition that may affect growth
- Child that has any chronic disease
- Child that has any carbohydrate metabolism disorder
- Child that takes any medications that may interfere with study parameters as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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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.
Aline Andres, Ph.D. principal investigator
University of Arkansas
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 1 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: withdrawn, as of the sponsor's last update on 7 Jan 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 7 Jan 2016.