Encouraging Calcium Absorption and Bone Formation During Early Puberty

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00022867
First received: August 14, 2001
Last updated: August 9, 2013
Last verified: August 2013
  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 1
Phase 2

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

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.

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

Publications:
Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00022867     History of Changes
Other Study ID Numbers: R01 AR43740, R01AR043740
Study First Received: August 14, 2001
Last Updated: August 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Bone growth
Calcium
Children
Diet
Puberty

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Puberty, Precocious
Bone Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014