Encouraging 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Nutrition Research Center at Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nondigestible oligosaccharide (NDO)

Drug

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

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

Registry information

Official study title

Optimization of Calcium Absorption and Bone Formation During Early Puberty

Important dates

Study start: 2001
Primary completion: 2005
Study completion: 2006
First posted: Aug 16, 2001
Registry last updated: Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed