NCT01897168

Brief Summary

The primary purpose of this study is to determine the effects of early diet on bone health.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

12.6 years

First QC Date

March 27, 2013

Last Update Submit

January 29, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bone health assessed by pQCT and DXA

    5-7 years

Study Arms (1)

No grouping

Device: No intervention

Interventions

No interventionDEVICE
No grouping

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine may be collected from study participants.

Study Officials

  • Jin-Ran Chen, Ph.D.

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

July 11, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations

US(1)