NCT00063037

Brief Summary

Calcium is important for healthy bone growth in children. Poor bone growth and development during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition education program designed to increase the amount of calcium children receive. The study will determine whether the program will result in long-term dietary changes and healthier bones in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 1999

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

June 19, 2003

Last Update Submit

June 23, 2005

Conditions

Osteoporosis

Keywords

Bone massCalcium intakePrevention of osteoporosisOptimizing peak bone massBone mineral density

Interventions

Behavioral modification - nutrition educationBEHAVIORAL

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Height or weight above the third percentile for age
  • Normal weight (\< 130% of desirable body weight)
  • English speaking

You may not qualify if:

  • Significant health condition
  • Medication known to affect growth (e.g., thyroxin, growth hormone, steroid medication)
  • Ritalin or Adderall medication
  • Significant developmental or delay impairment (e.g., autism, cerebral palsy, mental retardation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4399, United States

Location

Related Publications (1)

  • Weber DR, Stark LJ, Ittenbach RF, Stallings VA, Zemel BS. Building better bones in childhood: a randomized controlled study to test the efficacy of a dietary intervention program to increase calcium intake. Eur J Clin Nutr. 2017 Jun;71(6):788-794. doi: 10.1038/ejcn.2017.5. Epub 2017 Feb 22.

    PMID: 28225052DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Babette Zemel, Ph.D.

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2003

First Posted

June 20, 2003

Study Start

June 1, 1999

Study Completion

May 1, 2005

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(1)