Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022867
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2001-08-14
Brief Title:
Encouraging Calcium Absorption and Bone Formation During Early Puberty
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Optimization of Calcium Absorption and Bone Formation During Early Puberty
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR043740 | NIH | None | httpsreporternihgovquickSearchR01AR043740 |