Encouraging Calcium Absorption and Bone Formation During Early Puberty - Full Text View

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

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Optimization of Calcium Absorption and Bone Formation During Early Puberty

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment:	100
Study Start Date:	May 2001
Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	9 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022867

Locations


United States, Texas
	Children's Nutrition Research Center at Baylor College of Medicine
	Houston, Texas, United States, 77030

Sponsors and Collaborators

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

Investigators


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

More Information

Publications of Results:

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):471-6.

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.

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):945-53. Epub 2005 Jan 31.

Other Publications:

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

Study ID Numbers:	R01 AR43740, NIAMS-067
First Received:	August 14, 2001
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00022867
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Bone growth

Calcium

Children

Diet

Puberty

Study placed in the following topic categories:

Musculoskeletal Diseases

Gonadal Disorders

Puberty, Precocious

Precocious puberty

Endocrine System Diseases

Osteoporosis

Bone Diseases, Metabolic

Endocrinopathy

Bone Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	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