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Encouraging Calcium Absorption and Bone Formation During Early Puberty

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine Identifier:
First received: August 14, 2001
Last updated: July 23, 2015
Last verified: July 2015
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 Intervention Phase
Drug: Nondigestible oligosaccharide (NDO)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Optimization of Calcium Absorption and Bone Formation During Early Puberty

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment: 100
Study Start Date: May 2001
Study Completion Date: November 2006
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00022867

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)
Principal Investigator: Steven A. Abrams, MD Baylor College of Medicine
  More Information

Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine Identifier: NCT00022867     History of Changes
Other Study ID Numbers: R01AR043740 ( US NIH Grant/Contract Award Number )
Study First Received: August 14, 2001
Last Updated: July 23, 2015

Keywords provided by Baylor College of Medicine:
Bone growth

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Puberty, Precocious
Bone Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 24, 2017