Encouraging Calcium Absorption and Bone Formation During Early Puberty

Osteoporosis Clinical Trial

Official title:

Optimization of Calcium Absorption and Bone Formation During Early Puberty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022867
• Other study ID #: R01AR043740
• Secondary ID: R01AR043740
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 14, 2001
• Last updated: July 23, 2015
• Start date: May 2001
• Est. completion date: November 2006

Study information

• Verified date: July 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2006
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis
• Puberty, Precocious

Intervention

Drug:
• Nondigestible oligosaccharide (NDO)

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center at Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Abrams SA, Griffin IJ, Hawthorne KM, Chen Z, Gunn SK, Wilde M, Darlington G, Shypailo RJ, Ellis KJ. Vitamin D receptor Fok1 polymorphisms affect calcium absorption, kinetics, and bone mineralization rates during puberty. J Bone Miner Res. 2005 Jun;20(6):9 — View Citation

Abrams SA, Griffin IJ, Hawthorne KM, Gunn SK, Gundberg CM, Carpenter TO. Relationships among vitamin D levels, parathyroid hormone, and calcium absorption in young adolescents. J Clin Endocrinol Metab. 2005 Oct;90(10):5576-81. Epub 2005 Aug 2. — View Citation

Abrams SA, Griffin IJ, Hawthorne KM, Liang L, Gunn SK, Darlington G, Ellis KJ. A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralization in young adolescents. Am J Clin Nutr. 2005 Aug;82(2):4 — View Citation

Abrams SA, O'Brien KO. Calcium and bone mineral metabolism in children with chronic illnesses. Annu Rev Nutr. 2004;24:13-32. Review. — View Citation