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Encouraging Calcium Absorption and Bone Formation During Early Puberty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022867
Recruitment Status : Completed
First Posted : August 16, 2001
Last Update Posted : July 24, 2015
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Drug: Nondigestible oligosaccharide (NDO) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Optimization of Calcium Absorption and Bone Formation During Early Puberty
Study Start Date : May 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : November 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022867

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United States, Texas
Children's Nutrition Research Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Steven A. Abrams, MD Baylor College of Medicine
Publications of Results:
Other Publications:
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Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine Identifier: NCT00022867    
Other Study ID Numbers: R01AR043740 ( U.S. NIH Grant/Contract )
R01AR043740 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2001    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Steve Abrams, MD, Baylor College of Medicine:
Bone growth
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases