Encouraging Calcium Absorption and Bone Formation During Early Puberty
Primary Purpose
Osteoporosis, Osteopenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nondigestible oligosaccharide (NDO)
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone growth, Calcium, Children, Diet, Puberty
Eligibility 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
Sites / Locations
- Children's Nutrition Research Center at Baylor College of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00022867
First Posted
August 14, 2001
Last Updated
July 23, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00022867
Brief Title
Encouraging Calcium Absorption and Bone Formation During Early Puberty
Official Title
Optimization of Calcium Absorption and Bone Formation During Early Puberty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Bone growth, Calcium, Children, Diet, Puberty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nondigestible oligosaccharide (NDO)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Abrams, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center at Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15189111
Citation
Abrams SA, O'Brien KO. Calcium and bone mineral metabolism in children with chronic illnesses. Annu Rev Nutr. 2004;24:13-32. doi: 10.1146/annurev.nutr.24.012003.132135.
Results Reference
background
PubMed Identifier
16087995
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):471-6. doi: 10.1093/ajcn.82.2.471.
Results Reference
result
PubMed Identifier
16076940
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. doi: 10.1210/jc.2005-1021. Epub 2005 Aug 2.
Results Reference
result
PubMed Identifier
15883634
Citation
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. doi: 10.1359/JBMR.050114. Epub 2005 Jan 31.
Results Reference
result
Learn more about this trial
Encouraging Calcium Absorption and Bone Formation During Early Puberty
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