Encouraging Calcium Absorption and Bone Formation During Early Puberty - Tabular View

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Encouraging Calcium Absorption and Bone Formation During Early Puberty

This study has been completed.

Study NCT00022867. Last updated on March 27, 2007. Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Encouraging Calcium Absorption and Bone Formation During Early Puberty

Official Title ^†

Optimization of Calcium Absorption and Bone Formation During Early Puberty

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.

Detailed Description

Rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect increased bone mass. This study will examine if adding NDO to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. The study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth.

This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable kinetic study measuring calcium absorption will be performed. Participants will then be randomly assigned to receive calcium fortified food with or without added NDO for 1 year. Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic, hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA scan will be performed at the end of 2 years.

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Osteoporosis
Osteopenia

Intervention ^†

Drug: Nondigestible oligosaccharide (NDO)

MEDLINE PMIDs

16087995, 16076940, 15883634, 15189111

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

100

Start Date ^†

May 2001

Completion Date

November 2006

Eligibility Criteria ^†

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

Gender

Both

Ages

9 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00022867

Organization ID

R01 AR43740

Secondary IDs ^††

NIAMS-067

Study Sponsor ^†

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborators ^††

Investigators ^†

Principal Investigator:

Steven A. Abrams, MD

Baylor College of Medicine

Information Provided By

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Verification Date

March 2007

First Received Date ^†

August 14, 2001

Last Updated Date

March 27, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.