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Encouraging Calcium Absorption and Bone Formation During Early Puberty

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00022867
First received: August 14, 2001
Last updated: August 9, 2013
Last verified: August 2013

August 14, 2001
August 9, 2013
May 2001
January 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00022867 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Encouraging Calcium Absorption and Bone Formation During Early Puberty
Optimization of Calcium Absorption and Bone Formation During Early Puberty

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Osteoporosis
  • Osteopenia
Drug: Nondigestible oligosaccharide (NDO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2006
January 2005   (final data collection date for primary outcome measure)
  • 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
Both
9 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022867
R01 AR43740, R01AR043740
Yes
Steve Abrams, MD, Baylor College of Medicine
Baylor College of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Steven A. Abrams, MD Baylor College of Medicine
Baylor College of Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP