Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869422
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-05-11
Brief Title:
Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Randomised Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
PCLDIT
Brief Summary:
The goal of this study is to investigate the efficacy of a low dose iron supplement 6mg compared to a placebo tablet
Detailed Description:
The established therapy for iron-deficiency today is oral iron supplementation However this often leads to side effects such as constipation black stools nausea and abdominal pain There are some studies that have compared the efficacy of low-dose iron with normal-dose iron These showed that the side effects are dose-dependent Furthermore some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin In a pilot study with low-dose iron 6mg per tablet a significant increase in iron was shown which can be explained by a lower hepcidin release Therefore the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting Furthermore the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet Additionally a potential increase of low blood pressure to normal blood pressure will be investigated There will be two groups of women one group will be given a low-dose iron supplement of two tablets containing each 6mg for 3 months 90 days the other one will get two placebo tablet for 3 months accordingly
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