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| Sponsor: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00022867 |
Purpose
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 |
|---|---|---|
|
Osteoporosis Osteopenia |
Drug: Nondigestible oligosaccharide (NDO) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Optimization of Calcium Absorption and Bone Formation During Early Puberty |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2001 |
| Study Completion Date: | November 2006 |
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.
Eligibility| Ages Eligible for Study: | 9 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Contacts and Locations| United States, Texas | |
| Children's Nutrition Research Center at Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Steven A. Abrams, MD | Baylor College of Medicine |
More Information
| ClinicalTrials.gov Identifier: | NCT00022867 History of Changes |
| Other Study ID Numbers: | R01 AR43740, NIAMS-067 |
| Study First Received: | August 14, 2001 |
| Last Updated: | March 27, 2007 |
| Health Authority: | United States: Federal Government |
|
Bone growth Calcium Children Diet Puberty |
|
Bone Diseases, Metabolic Osteoporosis Puberty, Precocious Bone Diseases |
Musculoskeletal Diseases Gonadal Disorders Endocrine System Diseases |