Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459732
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2007-04-11
Brief Title:
Zinc Bone Health in Thalassemia The Think Zinc Study
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
UCSF Benioff Childrens Hospital Oakland
Study Overview
Official Title:
Zinc and Bone Metabolism in Thalassemia
Status:
COMPLETED
Status Verified Date:
2020-12
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:
ThinkZn
Brief Summary:
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia
Detailed Description:
The primary aim of this study is to determine if zinc supplementation improves bone health in young patients with thalassemia Osteoporosis is a significant co-morbidity in patients with thalassemia which leads to decreased quality of life The most effective way to prevent osteoporosis is to build strong dense bones in the early years A combination of disease endocrine and nutritional factors likely contribute to the etiology of osteoporosis in this population However even well transfused patients with normal gonadal function who are supplemented with calcium have low bone mass It is hypothesized that patients with thalassemia have low bone mass in part due to zinc deficiency Sub-optimal zinc status has been identified in patients with thalassemia and zinc supplementation has been shown to improve linear growth To test the primary hypothesis an 18 month randomized placebo-controlled trial of zinc supplementation 25 mg Znday vs placebo will be conducted in 60 young patients 6-30 yrs with thalassemia and low bone mass spine BMD Z-score -10 Bone health as estimated from measurements of bone mass by DXA and pQCT and markers of bone formation and resorption will be the primary outcome variables This will be the first study to examine the effects of zinc supplementation on bone health in patients with thalassemia If zinc supplementation is found to have a clinically important effect this simple safe non-invasive therapy could quickly become a part of the standard care of these young patients and improve overall health in children and adult patients with thalassemia
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 |
|---|---|---|---|
| K23HL076468 | NIH | None | httpsreporternihgovquickSearchK23HL076468 |