NCT00022867

Brief Summary

Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. The purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (NDO) or simple sugar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2001

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

3.7 years

First QC Date

August 14, 2001

Last Update Submit

July 23, 2015

Conditions

OsteoporosisOsteopenia

Keywords

Bone growthCalciumChildrenDietPuberty

Interventions

Nondigestible oligosaccharide (NDO)DRUG

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
* Tanner Stage 2 or 3 * Girls must not have started menstruating * In the 10th to 90th percentile in body mass index (BMI) for their age

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Children's Nutrition Research Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Abrams SA, O'Brien KO. Calcium and bone mineral metabolism in children with chronic illnesses. Annu Rev Nutr. 2004;24:13-32. doi: 10.1146/annurev.nutr.24.012003.132135.

    PMID: 15189111BACKGROUND

  • Abrams SA, Griffin IJ, Hawthorne KM, Liang L, Gunn SK, Darlington G, Ellis KJ. A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralization in young adolescents. Am J Clin Nutr. 2005 Aug;82(2):471-6. doi: 10.1093/ajcn.82.2.471.

    PMID: 16087995RESULT

  • Abrams SA, Griffin IJ, Hawthorne KM, Gunn SK, Gundberg CM, Carpenter TO. Relationships among vitamin D levels, parathyroid hormone, and calcium absorption in young adolescents. J Clin Endocrinol Metab. 2005 Oct;90(10):5576-81. doi: 10.1210/jc.2005-1021. Epub 2005 Aug 2.

    PMID: 16076940RESULT

  • Abrams SA, Griffin IJ, Hawthorne KM, Chen Z, Gunn SK, Wilde M, Darlington G, Shypailo RJ, Ellis KJ. Vitamin D receptor Fok1 polymorphisms affect calcium absorption, kinetics, and bone mineralization rates during puberty. J Bone Miner Res. 2005 Jun;20(6):945-53. doi: 10.1359/JBMR.050114. Epub 2005 Jan 31.

    PMID: 15883634RESULT

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Steven A. Abrams, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2001

First Posted

August 16, 2001

Study Start

May 1, 2001

Primary Completion

January 1, 2005

Study Completion

November 1, 2006

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

US(1)