Bone Mineral Content in Healthy Children | NCT01897168

Studies
Bone Mineral Content in Healthy Children

NCT01897168

Sponsor

Arkansas Children's Hospital Research Institute

Status

Active, not recruiting

Last Update Posted

Jan 30, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Healthy

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 27, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2025

Last Update Posted Date

Jan 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Label	Type	Description	Intervention Names
No grouping			Device: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Device		No grouping

Measure	Description	Time Frame
Bone health assessed by pQCT and DXA		5-7 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current or past participation in the Beginnings study (IRB#07180)
Age 5-7 years

Exclusion Criteria:

Growth or bone disorders
Non-removal metal on participant
Any other conditions that may affect the outcome of interest as determined by the PI.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Healthy children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Ran Chen, Ph.D.	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States