Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 12:47 PM
Study NCT ID:
NCT02683369
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women
Status:
COMPLETED
Status Verified Date:
2019-08
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:
Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.
Detailed Description:
The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.
Study Oversight
Has Oversight DMC:
False
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?: