Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05280821
Status:
TERMINATED
Last Update Posted:
2024-01-25
First Post:
2022-02-23
Brief Title:
Alternate Day vs Daily Iron Supplementation in Iron Depleted Women in the Philippines
Sponsor:
Swiss Federal Institute of Technology
Organization:
Swiss Federal Institute of Technology
Study Overview
Official Title:
Comparing Oral Iron Supplementation Using Alternate-day Dosing to the Standard of Care Consecutive-day Dosing in Iron-depleted Women With or Without Mild Anemia a Randomized Controlled Trial in the Philippines
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iron is very important for our body and performs vital tasks Iron deficiency is a worldwide health problem The prevalence of anemia in women of reproductive age in Southeast Asia is estimated to be 466 in 2019 with iron deficiency being one of the main reasons for anemia There are different approaches to treat iron deficiency One of them is the use of iron supplements Recommended iron supplement treatments today often differ in dose regimen and length Experts recommend a dose of 80-200 mg of iron taken either daily or on several days per week depending on the severity of the iron deficiency with or without anemia From certain guidelines lower amounts of iron are also recommended as this could lead to fewer side effectsPrevious studies have shown that both daily and multiple days per week administration can be effective in treating iron deficiency Recently several successive iron supplementation studies in Zurich showed that 24 h after ingestion of an oral dose of 60mg iron the absorption of iron in the body is impaired In addition it was measured that iron supplements taken only every other day instead of every day are absorbed about 30-50 better and have fewer side effects Little is known about the long-term effect of this alternating regimen on iron status and side effectsWith this 6-months study in the Philippines the investigators want to compare two different supplementation regimens with oral iron to see if there is any difference in the iron status intestinal inflammation levels and side effects and therefore if it would be better to take the iron supplements every 2 days instead of daily
Detailed Description:
None
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