Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285799
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-02-19
Brief Title:
Safety and Effectiveness of Iron Hydroxide Adipate Tartrate IHAT in Iron Deficient Premenopausal Women
Sponsor:
Nemysis Ltd
Organization:
Nemysis Ltd
Study Overview
Official Title:
A Randomised Double-blind Study to Determine the Safety and Efficacy of Iron Hydroxide Adipate Tartrate IHAT in Iron Deficient Premenopausal Women
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This is a double blind randomised placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate IHAT at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient but otherwise healthy premenopausal women over 12 weeks
Detailed Description:
This is a double blind randomised placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate IHAT at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient but otherwise healthy premenopausal women over 12 weeks
IHAT is a novel bioavailable source of iron It is a tartrate-modified nanoparticulate ferric oxo-hydroxide with similar functional properties and small primary particle size to the iron form found in the ferritin core ferrihydrite
In this trial subjects will be randomly assigned to receive either 1 IHAT once a day 2 IHAT twice a day or 3 a placebo daily for 12 weeks The primary endpoint is the correction of iron deficiency at week 12 Secondary endpoints include iron status iron deficiency symptoms and gastrointestinal symptoms over the course of the 12 weeks
IHAT is a novel bioavailable source of iron It is a tartrate-modified nanoparticulate ferric oxo-hydroxide with similar functional properties and small primary particle size to the iron form found in the ferritin core ferrihydrite
In this trial subjects will be randomly assigned to receive either 1 IHAT once a day 2 IHAT twice a day or 3 a placebo daily for 12 weeks The primary endpoint is the correction of iron deficiency at week 12 Secondary endpoints include iron status iron deficiency symptoms and gastrointestinal symptoms over the course of the 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None